(a) An over-the-counter cold, cough, allergy, bronchodilator, or antiasthmatic drug product in a form suitable for oral, inhalant, or topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part and each of the general conditions established in § 330.1.
(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
As used in this part:
(a) Bronchodilator drug. A drug used to overcome spasms that cause narrowing of the bronchial air tubes, such as in the symptomatic treatment of the wheezing and shortness of breath of asthma.
(b) Oral antitussive drug. A drug that either is taken by mouth or is dissolved in the mouth in the form of a lozenge and acts systemically to relieve cough.
(c) Topical antitussive drug. A drug that relieves cough when inhaled after being applied topically to the throat or chest in the form of an ointment or from a steam vaporizer, or when dissolved in the mouth in the form of a lozenge for a local effect.
(d) Expectorant drug. A drug taken orally to promote or facilitate the removal of secretions from the respiratory airways.
(e) Antihistamine drug. A drug used for the relief of the symptoms of hay fever and upper respiratory allergies (allergic rhinitis).
(f) Oral nasal decongestant drug. A drug that is taken by mouth and acts systemically to reduce nasal congestion caused by acute or chronic rhinitis.
(g) Topical nasal decongestant drug. A drug that when applied topically inside the nose, in the form of drops, jellies, or sprays, or when inhaled intranasally reduces nasal congestion caused by acute or chronic rhinitis.
(h) Calibrated dropper. A dropper calibrated such that the volume error incurred in measuring any liquid does not exceed 15 percent under normal use conditions.
(i) Effervescent dosage form. A dosage form intended to be dissolved in water before administration. It contains, in addition to the active ingredient(s), mixtures of acids (citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water.
The active ingredient of the product consists of any of the following when used within the dosage limits established for each ingredient:
(a) Brompheniramine maleate.
(b) Chlorcyclizine hydrochloride.
(c) Chlorpheniramine maleate.
(d) Dexbrompheniramine maleate.
(e) Dexchlorpheniramine maleate.
(f) Diphenhydramine citrate.
(g) Diphenhydramine hydrochloride.
(h) Doxylamine succinate.
(i) Phenindamine tartrate.
(j) Pheniramine maleate.
(k) Pyrilamine maleate.
(l) Thonzylamine hydrochloride.
(m) Triprolidine hydrochloride.
The active ingredients of the product consist of any of the following when used within the dosage limits and in the dosage forms established for each ingredient in § 341.74(d):
(a) Oral antitussives. (1) Chlophedianol hydrochloride.
(2) Codeine ingredients. The following ingredients may be used only in combination in accordance with § 290.2 and 21 CFR 1308.15(c).
(i) Codeine.
(ii) Codeine phosphate.
(iii) Codeine sulfate.
(3) Dextromethorphan.
(4) Dextromethorphan hydrobromide.
(5) Diphenhydramine citrate.
(6) Diphenhydramine hydrochloride.
(b) Topical antitussives. (1) Camphor.
(2) Menthol.
The active ingredients of the product consist of any of the following when used within the dosage limits established for each ingredient:
(a) Ephedrine.
(b) Ephedrine hydrochloride.
(c) Ephedrine sulfate.
(d) Epinephrine.
(e) Epinephrine bitartrate.
(f) Racephedrine hydrochloride.
(g) Racepinephrine hydrochloride.
The active ingredient of the product is guaifenesin when used within the dosage limits established in § 341.78(d).
The active ingredient of the product consists of any of the following when used within the dosage limits and in the dosage forms established for each ingredient:
(a) Oral nasal decongestants. (1) Phenylephrine hydrochloride.
(2) Pseudoephedrine hydrochloride.
(3) Pseudoephedrine sulfate.
(4) Phenylephrine bitartrate in an effervescent dosage form.
(b) Topical nasal decongestants. (1) Levmetamfetamine.
(2) Ephedrine.
(3) Ephedrine hydrochloride.
(4) Ephedrine sulfate.
(5) [Reserved]
(6) Naphazoline hydrochloride.
(7) Oxymetazoline hydrochloride.
(8) Phenylephrine hydrochloride.
(9) Propylhexedrine.
(10) Xylometazoline hydrochloride.
The following combinations are permitted provided each active ingredient is present within the dosage limits established in parts 341, 343, and 356 of this chapter and the product is labeled in accordance with §§ 341.70 or 341.85:
(a) Any single antihistamine active ingredient identified in § 341.12 may be combined with any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85.
(b) Any single antihistamine active ingredient identified in § 341.12 may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) provided that the product is labeled according to § 341.85.
(c) Any single antihistamine active ingredient identified in § 341.12 may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) and any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85.
(d) Any single antihistamine active ingredient identified in § 341.12(a) through (e) and (h) through (m) may be combined with any single oral antitussive active ingredient identified in § 341.14(a)(1) through (a)(4) provided that the product is labeled according to § 341.85(c)(4). Diphenhydramine citrate in §§ 341.12(f) and 341.14(a)(5) or diphenhydramine hydrochloride in §§ 341.12(g) and 341.14(a)(6) may be both the antihistamine and the antitussive active ingredient provided that the product is labeled according to § 341.70(a).
(e) Any single antihistamine active ingredient identified in § 341.12(a) through (e) and (h) through (m) may be combined with any single oral antitussive active ingredient identified in § 341.14(a)(1) through (a)(4) and any single oral nasal decongestant active ingredient identified in § 341.20(a) provided that the product is labeled according to § 341.85(c)(4). Diphenhydramine citrate in §§ 341.12(f) and 341.14(a)(5) or diphenhydramine hydrochloride in §§ 341.12(g) and 341.14(a)(6) may be both the antihistamine and the antitussive active ingredient provided that the product is labeled according to § 341.70(a).
(f) Any single antihistamine active ingredient identified in § 341.12(a) through (e) and (h) through (m) may be combined with any single oral antitussive active ingredient identified in § 341.14(a)(1) through (a)(4) and any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85(c)(4). Diphenhydramine citrate in §§ 341.12(f) and 341.14(a)(5) or diphenhydramine hydrochloride in §§ 341.12(g) and 341.14(a)(6) may be both the antihistamine and the antitussive active ingredient provided that the product is labeled according to § 341.70(a).
(g) Any single antihistamine active ingredient identified in § 341.12(a) through (e) and (h) through (m) may be combined with any single oral antitussive active ingredient identified in § 341.14(a)(1) through (a)(4) and any single oral nasal decongestant active ingredient identified in § 341.20(a) and any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85(c)(4). Diphenhydramine citrate in §§ 341.12(f) and 341.14(a)(5) or diphenhydramine hydrochloride in §§ 341.12(g) and 341.14(a)(6) may be both the antihistamine and the antitussive active ingredient provided that the product is labeled according to § 341.70(a).
(h) Any single oral antitussive active ingredient identified in § 341.14(a)(1) through (a)(4) may be combined with any single expectorant active ingredient identified in § 341.18 provided that the product is labeled according to § 341.85.
(i) Any single oral antitussive active ingredient identified in § 341.14(a) may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) provided that the product is labeled according to § 341.85.
(j) Any single oral antitussive active ingredient identified in § 341.14(a)(1) through (a)(4) may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) and any single expectorant active ingredient identified in § 341.18 provided that the product is labeled according to § 341.85.
(k) Any single antitussive active ingredient identified in § 341.14(a) or (b)(2) may be combined with any generally recognized as safe and effective single oral anesthetic/analgesic active ingredient, or any combination of anesthetic/analgesic active ingredients provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to § 341.85. If the combination contains a topical antitussive, the product must be formulated in a solid dosage form to be dissolved in the mouth. Menthol in § 341.14(b)(2) and part 356 of this chapter may be both the antitussive and the anesthetic/analgesic active ingredient provided that the product is labeled according to § 341.70(b).
(l) Any single oral antitussive active ingredient identified in § 341.14(a) may be combined with any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85.
(m) Any single oral antitussive active ingredient identified in § 341.14(a) may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) and any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85.
(n) Any single oral antitussive active ingredient identified in § 341.14(a)(1) through (a)(4) may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) and any single expectorant active ingredient identified in § 341.18 and any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85.
(o) Any single expectorant active ingredient identified in § 341.18 may be combined with any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85.
(p) Any single expectorant active ingredient identified in § 341.18 may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) provided that the product is labeled according to § 341.85.
(q) Any single expectorant active ingredient identified in § 341.18 may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) and any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85.
(r) Any single oral nasal decongestant active ingredient identified in § 341.20(a) may be combined with any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85.
(s) Any single oral nasal decongestant active ingredient identified in § 341.20(a) may be combined with any generally recognized as safe and effective single oral anesthetic/analgesic active ingredient identified, or any combination of anesthetic/analgesic active ingredients provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to § 341.85.
(t) Any single oral nasal decongestant active ingredient identified in § 341.20(a) may be combined with any single antitussive active ingredient identified in § 341.14(a) or (b)(2) and any generally recognized as safe and effective single oral anesthetic/analgesic active ingredient, or any combination of anesthetic/analgesic active ingredients provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to § 341.85. If the combination contains a topical antitussive, the product must be formulated in a solid dosage form to be dissolved in the mouth.
(u) Camphor identified in § 341.14(b)(1) may be combined with menthol identified in § 341.14(b)(2) and eucalyptus oil (1.2 to 1.3 percent) provided that the product is available only in a suitable ointment vehicle and provided that the product is labeled according to § 341.85.
(v) Levmetamfetamine identified in § 341.20(b)(1) may be combined with aromatics (camphor (54 milligrams (mg)), menthol (80 mg), methyl salicylate (11 mg), and lavender oil (4 mg)) provided that the product is available only as a nasal inhaler and provided that the product is labeled according to § 341.85.
(w) Any single antitussive active ingredient identified in § 341.14(a) or (b)(2) may be combined with any generally recognized as safe and effective single oral demulcent active ingredient provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to § 341.85. If the combination contains a topical antitussive, the product must be formulated in a solid dosage form to be dissolved in the mouth.
(x) Any single oral nasal decongestant active ingredient identified in § 341.20(a) may be combined with any generally recognized as safe and effective single oral demulcent active ingredient provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to § 341.85.
(y) Any single antitussive active ingredient identified in § 341.14(a) or (b)(2) may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) and any generally recognized as safe and effective single oral demulcent active ingredient provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to § 341.85. If the combination contains a topical antitussive, the product must be formulated in a solid dosage form to be dissolved in the mouth.
(z) Any single antitussive active ingredient identified in § 341.14(a) or (b)(2) may be combined with any generally recognized as safe and effective single oral anesthetic/analgesic active ingredient or any combination of anesthetic/analgesic active ingredients and any generally recognized as safe and effective single oral demulcent active ingredient provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to § 341.85. If the combination contains a topical antitussive, the product must be formulated in a solid dosage form to be dissolved in the mouth.
(aa) Any single oral nasal decongestant active ingredient identified in § 341.20(a) may be combined with any generally recognized as safe and effective single oral anesthetic/analgesic active ingredient or any combination of oral anesthetic/analgesic active ingredients and any generally recognized as safe and effective single oral demulcent active ingredient provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to § 341.85.
(bb) Any single antitussive active ingredient identified in § 341.14(a) or (b)(2) may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) and any generally recognized as safe and effective single oral anesthetic/analgesic active ingredient identified or any combination of anesthetic/analgesic active ingredients and any generally recognized as safe and effective single oral demulcent active ingredient provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to § 341.85. If the combination contains a topical antitussive, the product must be formulated in a solid dosage form to be dissolved in the mouth.
The statements of identity, indications, warnings, and directions for use, respectively, applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable.
(a) For products containing diphenhydramine citrate and diphenhydramine hydrochloride identified in § 341.14(a)(5) and (a)(6). The labeling of the product contains the established name of the drug, if any, and identifies the product as an “antihistamine/cough suppressant” or “antihistamine/antitussive (cough suppressant).” The indications shall be combined from §§ 341.72(b) and 341.74(b). The warnings shall be combined from §§ 341.72(c)(1), (c)(2), (c)(4), and (c)(6) and 341.74(c)(1), (c)(2), (c)(3), and (c)(4). Alternatively, all of the warnings in § 341.74(c) shall be used. The directions for OTC labeling shall follow §§ 341.74(d)(1)(iv) or (d)(1)(v), as applicable. The directions for professional labeling shall follow § 341.90(j) or (k), as applicable.
(b) For products containing menthol identified in §§ 341.14(b)(2) and 356.12(f) of this chapter. The product contains 5 to 10 milligrams menthol. The labeling of the product contains the established name of the drug, if any, and identifies the product as a “cough suppressant/oral anesthetic” or “antitussive (cough suppressant)/oral anesthetic.” The indications shall be combined from § 341.74(b) and part 356 of this chapter. The warnings shall be combined from § 341.74(c)(1), (c)(2), and (c)(3) and part 356 of this chapter. The directions shall be: “Directions [in bold type] [bullet]
(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an “antihistamine.”
(b) Indications. The labeling of the product states, under the heading “Indications,” any of the phrases listed in paragraph (b) of this section, as appropriate. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph, may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.
(1) “Temporarily” (select one of the following: “relieves,” “alleviates,” “decreases,” “reduces,” or “dries”) “runny nose and” (select one of the following: “relieves,” “alleviates,” “decreases,” or “reduces”) “sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever” (which may be followed by one or both of the following: “or other upper respiratory allergies” or “(allergic rhinitis)”).
(2) “For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever” (which may be followed by one or both of the following: “or other upper respiratory allergies” or “(allergic rhinitis)”).
(c) Warnings. The labeling of the product contains the following warnings, under the heading “Warnings”:
(1) “May cause excitability especially in children.”
(2) “Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland.”
(3) For products containing brompheniramine maleate, chlorcyclizine hydrochloride, chlorpheniramine maleate, dexbrompheniramine maleate, dexchlorpheniramine maleate, phenindamine tartrate, pheniramine maleate, pyrilamine maleate, thonzylamine hydrochloride, or triprolidine hydrochloride identified in § 341.12(a), (b), (c), (d), (e), (i), (j), (k), (l), and (m). “May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.”
(4) For products containing diphenhydramine citrate, diphenhydramine hydrochloride, or doxylamine succinate identified in § 341.12(f), (g), and (h). “May cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.”
(5) For products containing phenindamine tartrate identified in § 341.12(i). “May cause nervousness and insomnia in some individuals.”
(6) For products that are labeled only for use by children under 12 years of age. The labeling of the product contains only the warnings identified in paragraphs (c)(1) and (c)(5) of this section as well as the following:
(i) “Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's doctor.”
(ii) For products containing brompheniramine maleate, chlorpheniramine maleate, dexbrompheniramine maleate, dexchlorpheniramine maleate, phenindamine tartrate, pheniramine maleate, pyrilamine maleate, thonzylamine hydrochloride, or triprolidine hydrochloride identified in § 341.12(a), (c), (d), (e), (i), (j), (k), (l), and (m). “May cause drowsiness. Sedatives and tranquilizers may increase the drowsiness effect. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's doctor.”
(iii) For products containing diphenhydramine citrate, diphenhydramine hydrochloride, or doxylamine succinate identified in § 341.12(f), (g), and (h). “May cause marked drowsiness. Sedatives and tranquilizers may increase the drowsiness effect. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's doctor.”
(iv) For products containing diphenhydramine citrate or diphenhydramine hydrochloride identified in § 341.12(f) and (g). “Do not use [bullet]
(7) For products containing diphenhydramine citrate or diphenhydramine hydrochloride identified in § 341.12(f) and (g). “Do not use [bullet] with any other product containing diphenhydramine, even one used on skin”.
(d) Directions. The labeling of the product contains the following information under the heading “Directions”:
(1) For products containing brompheniramine maleate identified in § 341.12(a). Adults and children 12 years of age and over: oral dosage is 4 milligrams every 4 to 6 hours, not to exceed 24 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 2 milligrams every 4 to 6 hours, not to exceed 12 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.
(2) For products containing chlorcyclizine hydrochloride identified in § 341.12(b). Adults and children 12 years of age and over: oral dosage is 25 milligrams every 6 to 8 hours, not to exceed 75 milligrams in 24 hours, or as directed by a doctor. Children under 12 years of age: consult a doctor.
(3) For products containing chlorpheniramine maleate identified in § 341.12(c). Adults and children 12 years of age and over: oral dosage is 4 milligrams every 4 to 6 hours, not to exceed 24 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 2 milligrams every 4 to 6 hours, not to exceed 12 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.
(4) For products containing dexbrompheniramine maleate identified in § 341.12(d). Adults and children 12 years of age and over: oral dosage is 2 milligrams every 4 to 6 hours, not to exceed 12 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 1 milligram every 4 to 6 hours, not to exceed 6 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.
(5) For products containing dexchlorpheniramine maleate identified in § 341.12(e). Adults and children 12 years of age and over: oral dosage is 2 milligrams every 4 to 6 hours, not to exceed 12 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 1 milligram every 4 to 6 hours, not to exceed 6 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.
(6) For products containing diphenhydramine citrate identified in § 341.12(f). Adults and children 12 years of age and over: oral dosage is 38 to 76 milligrams every 4 to 6 hours, not to exceed 456 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 19 to 38 milligrams every 4 to 6 hours, not to exceed 228 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.
(7) For products containing diphenhydramine hydrochloride identified in § 341.12(g). Adults and children 12 years of age and over: oral dosage is 25 to 50 milligrams every 4 to 6 hours, not to exceed 300 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 12.5 to 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.
(8) For products containing doxylamine succinate identified in § 341.12(h). Adults and children 12 years of age and over: oral dosage is 7.5 to 12.5 milligrams every 4 to 6 hours, not to exceed 75 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 3.75 to 6.25 milligrams every 4 to 6 hours, not to exceed 37.5 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.
(9) For products containing phenindamine tartrate identified in § 341.12(i). Adults and children 12 years of age and over: oral dosage is 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 12.5 milligrams every 4 to 6 hours, not to exceed 75 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.
(10) For products containing pheniramine maleate identified in § 341.12(j). Adults and children 12 years of age and over: oral dosage is 12.5 to 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 6.25 to 12.5 milligrams every 4 to 6 hours, not to exceed 75 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.
(11) For products containing pyrilamine maleate identified in § 341.12(k). Adults and children 12 years of age and over: oral dosage is 25 to 50 milligrams every 6 to 8 hours, not to exceed 200 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 12.5 to 25 milligrams every 6 to 8 hours, not to exceed 100 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.
(12) For products containing thonzylamine hydrochloride identified in § 341.12(l). Adults and children 12 years of age and over: oral dosage is 50 to 100 milligrams every 4 to 6 hours, not to exceed 600 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 25 to 50 milligrams every 4 to 6 hours, not to exceed 300 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.
(13) For products containing triprolidine hydrochloride identified in § 341.12(m). Adults and children 12 years of age and over: oral dosage is 2.5 milligrams every 4 to 6 hours, not to exceed 10 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 1.25 milligrams every 4 to 6 hours, not to exceed 5 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.
(e) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section.
(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as a “cough suppressant” or an “antitussive (cough suppressant).”
(b) Indications. The labeling of the product states, under the heading “Indications,” any of the phrases listed in this paragraph (b), as appropriate. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph, may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.
(1) “Temporarily” (select one of the following: “alleviates,” “calms,” “controls,” “decreases,” “quiets,” “reduces,” “relieves,” or “suppresses”) “cough due to” (select one of the following: “minor bronchial irritation” or “minor throat and bronchial irritation”) (select one of the following: “as may occur with,” “associated with,” or “occurring with”) (select one of the following: “A cold” or “the common cold”) “or inhaled irritants.”
(2) “Temporarily” (select one of the following: “alleviates,” “calms,” “controls,” “decreases,” “quiets,” “reduces,” “relieves,” or “suppresses”) “cough” (select one of the following: “as may occur with,” “associated with,” or “occurring with”) (select one of the following: “A cold,” “the common cold,” or “inhaled irritants”).
(3) In addition to the required information identified in paragraphs (b) (1) and (2) of this section, the labeling of the product may contain any (one or more) of the following statements:
(i) “Cough suppressant which temporarily” (select one of the following: “Alleviates,” “controls,” “decreases,” “reduces,” “relieves,” or “suppresses”) “the impulse to cough.”
(ii) “Temporarily helps you cough less.”
(iii) “Temporarily helps to” (select one of the following: “Alleviate,” “control,” “decrease,” “reduce,” “relieve,” or “suppress”) “the cough reflex that causes coughing.”
(iv) “Temporarily” (select one of the following: “Alleviates,” “controls,” “decreases,” “reduces,” “relieves,” or “suppresses”) “the intensity of coughing.”
(v) (Select one of the following: “Alleviates,” “Controls,” “Decreases,” “Reduces,” “Relieves,” or “Suppresses”) (select one of the following: “Cough,” “the impulse to cough,” or “your cough”) “to help you” (select one of the following: “Get to sleep,” “sleep,” or “rest”).
(vi) For products containing chlophedianol hydrochloride, codeine ingredients, dextromethorphan, or dextromethorphan hydrobromide identified in § 341.14(a) (1), (2), (3), and (4). “Calms the cough control center and relieves coughing.”
(vii) For products containing chlophedianol hydrochloride, dextromethorphan, dextromethorphan hydrobromide, camphor, or menthol identified in § 341.14(a) (1), (3), (4) and (b) (1) and (2). (a) “Nonnarcotic cough suppressant for the temporary” (select one of the following: “alleviation,” “control,” “decrease,” “reduction,” “relief,” or “suppression”) “of cough.”
(b) (Select one of the following: “Alleviates,” “Controls,” “Decreases,” “Reduces,” “Relieves,” or “Suppresses”) “cough impulses without narcotics.”
(c) Warnings. The labeling of the product contains the following warnings under the heading “Warnings”:
(1) For oral and topical antitussives. “A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.”
(2) For oral and topical antitussives labeled for adults or for adults and children under 12 years of age. “Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.”
(3) For oral and topical antitussives labeled only for children under 12 years of age. “Do not give this product for persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.”
(4) Oral antitussives - (i) For products containing codeine ingredients identified in § 341.14(a)(2). “May cause or aggravate constipation.”
(ii) For products containing codeine ingredients identified in § 341.14(a)(2) when labeled only for adults. “Do not take this product if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.”
(iii) For products containing codeine ingredients identified in § 341.14(a)(2) when labeled only for children under 12 years of age. “Do not give this product to children who have a chronic pulmonary disease, shortness of breath, or who are taking other drugs unless directed by a doctor.”
(iv) For products containing codeine ingredients identified in § 341.14(a)(2) when labeled for use in adults and children under 12 years of age. “Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a doctor.”
(v) For products containing dextromethorphan or dextromethorphan hydrobromide as identified in § 341.14 (a)(3) and (a)(4) when labeled for adults or for adults and children under 12 years of age. Drug interaction precaution. “Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.”
(vi) For products containing dextromethorphan or dextromethorphan hydrobromide as identified in § 341.14 (a)(3) and (a)(4) when labeled only for children under 12 years of age. Drug interaction precaution. “Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.”
(vii) For products containing diphenhydramine citrate or diphenhydramine hydrochloride identified in § 341.14 (a)(5) and (a)(6). “May cause excitability especially in children.”
(viii) For products containing diphenhydramine citrate or diphenhydramine hydrochloride identified in § 341.14 (a)(5) and (a)(6) when labeled only for children under 12 years of age - (A) “Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's doctor.”
(B) “May cause marked drowsiness. Sedatives and tranquilizers may increase the drowsiness effect. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's doctor.”
(C) “Do not use [bullet]
(ix) For products containing diphenhydramine citrate or diphenhydramine hydrochloride identified in § 341.14 (a)(5) and (a)(6) when labeled for use in adults and children under 12 years of age - (A) “Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland.”
(B) “May cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.”
(C) “Do not use [bullet] with any other product containing diphenhydramine, even one used on skin”.
(5) Topical antitussives - (i) For products containing camphor or menthol identified in § 341.14 (b) (1) and (2) in a suitable ointment vehicle. “For external use only. Do not take by mouth or place in nostrils.”
(ii) For products containing camphor or menthol identified in § 341.14(b) (1) and (2) for steam inhalation use. “For steam inhalation only. Do not take by mouth.”
(iii) For any product containing camphor or menthol in a suitable ointment vehicle or for steam inhalation use and meets the definition of one of the signal words (“extremely flammable,” “flammable,” “combustible”) as described in 16 CFR 1500.3(b)(10). The labeling contains the appropriate flammability signal word(s) followed by a colon and the statement “Keep away from fire or flame.”
(iv) For any product containing camphor or menthol in a suitable ointment vehicle and that does not contain a flammability signal word as described in 16 CFR 1500.3(b)(10). “When using this product, do not [bullet]
(v) For any product containing camphor or menthol in a suitable ointment vehicle and that contains a flammability signal word as described in 16 CFR 1500.3(b)(10). “When using this product, do not [bullet] heat [bullet] microwave [bullet] use near an open flame [bullet] add to hot water or any container where heating water. May cause splattering and result in burns.” [Information highlighted in bold type.]
(vi) For any product containing camphor or menthol for steam inhalation use. “When using this product, do not [bullet] heat [bullet] microwave [bullet] use near an open flame [bullet] add to hot water or any container where heating water except when adding to cold water only in a hot steam vaporizer. May cause splattering and result in burns.” [Information highlighted in bold type.]
(vii) For any product formulated in a volatile vehicle. The labeling contains the following statement under the heading “Other information”: “Close container tightly and store at room temperature away from heat.”
(d) Directions. The labeling of the product contains the following information under the heading “Directions”:
(1) Oral antitussives - (i) For products containing chlophedianol hydrochloride identified in § 341.14(a)(1). Adults and children 12 years of age and over: Oral dosage is 25 milligrams every 6 to 8 hours, not to exceed 100 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: Oral dosage is 12.5 milligrams every 6 to 8 hours, not to exceed 50 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor.
(ii) For products containing codeine ingredients identified in § 341.14(a)(2). Adults and children 12 years of age and over: Oral dosage is 10 to 20 milligrams every 4 to 6 hours, not to exceed 120 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: Oral dosage is 5 to 10 milligrams every 4 to 6 hours, not to exceed 60 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.
(iii) For products containing dextromethorphan or dextromethorphan hydrobromide identified in § 341.14(a) (3) and (4). The dosage is equivalent to dextromethorphan hydrobromide. Adults and children 12 years of age and over: Oral dosage is 10 to 20 milligrams every 4 hours or 30 milligrams every 6 to 8 hours, not to exceed 120 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: Oral dosage is 5 to 10 milligrams every 4 hours or 15 milligrams every 6 to 8 hours, not to exceed 60 milligrams in 24 hours, or as directed by a doctor. Children 2 to under 6 years of age: Oral dosage is 2.5 to 5 milligrams every 4 hours or 7.5 milligrams every 6 to 8 hours, not to exceed 30 milligrams in 24 hours, or as directed by a doctor. Children under 2 years of age: Consult a doctor.
(iv) For products containing diphenhydramine citrate identified in § 341.14(a)(5). Adults and children 12 years of age and over: oral dosage is 38 milligrams every 4 hours, not to exceed 228 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 19 milligrams every 4 hours, not to exceed 114 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.
(v) For products containing diphenhydramine hydrochloride identified in § 341.14(a)(6). Adults and children 12 years of age and over: oral dosage is 25 milligrams every 4 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 12.5 milligrams every 4 hours, not to exceed 75 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.
(2) Topical antitussives - (i) For products containing camphor identified in § 341.14(b)(1) in a suitable ointment vehicle. The product contains 4.7 to 5.3 percent camphor. “[bullet] see important warnings under ‘When using this product’ [appears as the first statement under the heading “Directions” and is highlighted in bold type] [bullet] adults and children 2 years and older: [bullet] rub on the throat and chest in a thick layer [bullet] cover with a warm, dry cloth if desired [bullet] clothing should be loose about throat and chest to help vapors reach the nose and mouth [bullet] use up to three times daily or as directed by a doctor [bullet] children under 2 years of age: Ask a doctor.
(ii) For products containing menthol identified in § 341.14(b)(2) in a suitable ointment vehicle. The product contains 2.6 to 2.8 percent menthol. “[bullet] see important warnings under 'When using this product' ” [appears as the first statement under the heading “Directions” and is highlighted in bold type] [bullet] adults and children 2 years and older: [bullet] rub on the throat and chest in a thick layer [bullet] cover with a warm, dry cloth if desired [bullet] clothing should be loose about throat and chest to help vapors reach the nose and mouth [bullet] use up to three times daily or as directed by a doctor [bullet] children under 2 years of age: Ask a doctor.
(iii) For products containing menthol identified in § 341.14(b)(2) in a lozenge. The product contains 5 to 10 milligrams menthol. Adults and children 2 to under 12 years of age: Allow lozenge to dissolve slowly in the mouth. May be repeated every hour as needed or as directed by a doctor. Children under 2 years of age: Consult a doctor.
(iv) For products containing camphor identified in § 341.14(b)(1) for steam inhalation use. The product contains 6.2 percent camphor. “[bullet] see important warnings under ‘When using this product’ ” [appears as the first statement under the heading “Directions” and is highlighted in bold type] [bullet] adults and children 2 years and older: (select one of the following, as appropriate: For products formulated to be added directly to cold water inside a hot steam vaporizer. [bullet] use 1 tablespoonful of solution for each quart of water or 1
(v) For products containing menthol identified in § 341.14(b)(2) for steam inhalation use. The product contains 3.2 percent menthol. “[bullet] see important warnings under ‘When using this product’ ”[appears as the first statement under the heading “Directions” and is highlighted in bold type] [bullet] adults and children 2 years and older: (select one of the following, as appropriate: For products formulated to be added directly to cold water inside a hot steam vaporizer. [bullet] use 1 tablespoonful of solution for each quart of water or 1
(e) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section.
(f) Exemption from the general accidental overdose warning. The labeling for antitussive drug products containing the active ingredient identified in § 341.14(b)(2) marketed in accordance with § 341.74(d)(2)(iii) is exempt from the requirement in § 330.1(g) of this chapter that the labeling bear the general warning statement “In case of accidental overdose, seek professional assistance or contact a poison control center immediately.” The labeling must continue to bear the first part of the general warning in § 330.1(g) of this chapter, which states, “Keep this and all drugs out of the reach of children.”
(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as a “bronchodilator.”
(b) Indication. The labeling of the product states the following under the heading “Use”: “for temporary relief of mild symptoms of intermittent asthma: [bullet]
(c) Warnings. The labeling of the product contains the following warnings under the heading “Warnings”:
(1) The following statements shall appear after the subheading “Do not use” [in bold type]:
(i) “[Bullet] unless a doctor said you have asthma”.
(ii) “[Bullet] if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.”
(2) The following information shall appear after the subheading “Ask a doctor before use if you have” [in bold type]: “[bullet] ever been hospitalized for asthma [bullet] heart disease [bullet] high blood pressure [bullet] diabetes [bullet] thyroid disease [bullet] seizures [bullet] narrow angle glaucoma [bullet] a psychiatric or emotional condition [bullet] trouble urinating due to an enlarged prostate gland”.
(3) The following information shall appear after the subheading “Ask a doctor or pharmacist before use if you are” [in bold type]:
(i) “[Bullet] taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions”.
(ii) “[Bullet] taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)”.
(4) The following information shall appear after the subheading “When using this product” [in bold type]:
(i) “[Bullet] your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.” [in bold type]
(ii) “[Bullet] your risk of heart attack or stroke increases if you: [Bullet] have a history of high blood pressure or heart disease [Bullet] take this product more frequently or take more than the recommended dose”. [in bold type]
(iii) “[Bullet] avoid foods or beverages that contain caffeine”.
(iv) “[Bullet] avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect”.
(5) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, or racephedrine hydrochloride identified in § 341.16(a), (b), (c), and (f). (i) The following information shall appear after the subheading “Asthma alert: Because asthma may be life threatening, see a doctor if you” [in bold type]:
(A) “[Bullet] are not better in 60 minutes”.
(B) “[Bullet] get worse”.
(C) “[Bullet] need more than [insert total number of dosage units that equals 150 milligrams] in 24 hours”.
(D) “[Bullet] use more than [insert total number of dosage units that equals 100 milligrams] in 24 hours for 3 or more days a week”.
(E) “[Bullet] have more than 2 asthma attacks in a week”.
(F) “These may be signs that your asthma is getting worse.”
(G) “[Bullet] This product will not give you asthma relief as quickly as an inhaled bronchodilator.”
(ii) This “Asthma alert” shall appear on any labeling that contains warnings and shall be the first warning statement under the heading “Warnings”.
(6) For products containing epinephrine, epinephrine bitartrate, or racepinephrine hydrochloride identified in § 341.16(d), (e), and (g). (i) The following information shall appear after the subheading “Asthma alert: Because asthma may be life threatening, see a doctor if you” [in bold type]:
(A) “[Bullet] are not better in 20 minutes”.
(B) “[Bullet] get worse”.
(C) “[Bullet] need more than 12 inhalations in 24 hours”.
(D) “[Bullet] use more than 9 inhalations in 24 hours for 3 or more days a week”.
(E) “[Bullet] have more than 2 asthma attacks in a week”.
(F) “These may be signs that your asthma is getting worse.”
(ii) This “Asthma alert” shall appear on any labeling that contains warnings and shall be the first warning statement under the heading “Warnings.”
(iii) For products intended for use in a hand-held rubber bulb nebulizer. The following statement shall also appear after the subheading “Do not use” along with the other information in paragraph (c)(1) of this section: “[bullet] if product is brown in color or cloudy”.
(7) The following information shall appear after the subheading “Stop use and ask a doctor if” [in bold type]:
(i) “[Bullet] your asthma is getting worse (see Asthma alert)”.
(ii) “[Bullet] you have difficulty sleeping”.
(iii) “[Bullet] you have a rapid heart beat”.
(iv) “[Bullet] you have tremors, nervousness, or seizure”.
(d) Directions. The labeling of the product contains the following information under the heading “Directions”:
(1) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, or racephedrine hydrochloride identified in § 341.16(a), (b), (c), and (f): (i) “[Bullet] do not take more than directed” [sentence appears as first bulleted statement under “Directions” and in bold type]
(ii) “[Bullet] adults and children 12 years of age and over: oral dose is 12.5 to 25 milligrams every 4 hours as needed. Do not take more than 150 milligrams in 24 hours”.
(iii) “[Bullet] children under 12 years of age: ask a doctor”.
(2) For products containing epinephrine, epinephrine bitartrate, and racepinephrine hydrochloride identified in § 341.16(d), (e), and (g) for use in a hand-held rubber bulb nebulizer. The ingredient is used in an aqueous solution at a concentration equivalent to 1-percent epinephrine:
(i) “[Bullet] do not use more than directed” [appears as first bulleted statement under “Directions” and in bold type].
(ii) “[Bullet] adults and children 4 years of age and over: 1 to 3 inhalations not more often than every 3 hours. Do not use more than 12 inhalations in 24 hours. The use of this product by children should be supervised by an adult.”
(iii) “[Bullet] children under 4 years of age: ask a doctor”.
(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an “expectorant.”
(b) Indications. The labeling of the product states, under the heading “Indications,” the following: “Helps loosen phlegm (mucus) and thin bronchial secretions to” (select one or more of the following: “rid the bronchial passageways of bothersome mucus,” “drain bronchial tubes,” and “make coughs more productive”). Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.
(c) Warnings. The labeling of the product contains the following warnings, under the heading “Warnings”:
(1) “A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.”
(2) For expectorant drug products labeled for adults or for adults and children under 12 years of age. “Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.”
(3) For expectorant drug products labeled only for children under 12 years of age. “Do not give this product for persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.”
(d) Directions. The labeling of the product contains the following information under the heading “Directions” for products containing guaifenesin identified in § 341.18: Adults and children 12 years of age and over: oral dosage is 200 to 400 milligrams every 4 hours not to exceed 2,400 milligrams in 24 hours. Children 6 to under 12 years of age: oral dosage is 100 to 200 milligrams every 4 hours not to exceed 1,200 milligrams in 24 hours. Children 2 to under 6 years of age: oral dosage is 50 to 100 milligrams every 4 hours not to exceed 600 milligrams in 24 hours. Children under 2 years of age: consult a doctor.
(e) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section.
(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as a “nasal decongestant.”
(b) Indications. The labeling of the product states, under the heading “Indications,” the phrase listed in paragraph (b)(1) of this section, as appropriate, and may contain any additional phrases listed in paragraph (b)(2) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in paragraphs (b)(1) and (b)(2) of this section, may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.
(1) (Select one of the following: “For the temporary relief of nasal congestion” or “Temporarily relieves nasal congestion”) (which may be followed by any of the following in paragraphs (b)(1) (i), (ii), and (iii) of this section):
(i) “due to” (select one of the following: “the common cold” or “a cold”).
(ii) “due to” (select one of the following: “hay fever,” “hay fever (allergic rhinitis),” “hay fever or other upper respiratory allergies,” or “hay fever or other upper respiratory allergies (allergic rhinitis)”).
(2) In addition to the information identified in paragraph (b)(1) of this section, the labeling of the product may contain any (one or more) of the following statements:
(i) (Select one of the following: “For the temporary relief of” or “Temporarily relieves”) (select one of the following: “stuffy nose,” “stopped up nose,” “nasal stuffiness,” or “clogged up nose.”)
(ii) (Select one of the following: “Reduces swelling of,” “Decongests,” or “Helps clear”) “nasal passages; shrinks swollen membranes.”
(iii) “Temporarily restores freer breathing through the nose.”
(iv) “Helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure.”
(v) “Promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure.”
(c) Warnings. The labeling of the product contains the following warnings under the heading “Warnings”:
(1) Oral nasal decongestants - (i) For products containing phenylephrine hydrochloride, pseudoephedrine hydrochloride, pseudoephedrine sulfate, or phenylephrine bitartrate identified in § 341.20 (a)(1) through (a)(4) when labeled for adults. (A) “Do not exceed recommended dosage. [first sentence in boldface type] If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.”
(B) “If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.”
(C) “Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.”
(D) Drug interaction precaution. “Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.”
(ii) For products containing phenylephrine hydrochloride, pseudoephedrine hydrochloride, pseudoephedrine sulfate, or phenylephrine bitartrate identified in § 341.20 (a)(1) through (a)(4) when labeled for children under 12 years of age. (A) “Do not exceed recommended dosage. [first sentence in boldface type] If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.”
(B) “If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.”
(C) “Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.”
(D) Drug interaction precaution. “Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.”
(iii) For oral nasal decongestant products labeled for both adults and children under 12 years of age. The labeling of the product contains the warnings identified in paragraph (c)(1)(i) of this section.
(2) Topical nasal decongestants - (i) For products containing any topical nasal decongestant identified in § 341.20(b) when labeled for adults. (A) “Do not exceed recommended dosage.” [sentence in boldface type]
(B) “This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.”
(C) “The use of this container by more than one person may spread infection.”
(ii) For products containing levmetamfetamine identified in § 341.20(b)(1) when used in an inhalant dosage form and when labeled for adults. “Do not use this product for more than 7 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, ask a doctor.”
(iii) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, naphazoline hydrochloride, oxymetazoline hydrochloride, phenylephrine hydrochloride, or xylometazoline hydrochloride identified in § 341.20 (b)(2), (b)(3), (b)(4), (b)(6), (b)(7), (b)(8), and (b)(10) when used as nasal sprays, drops, or jellies and when labeled for adults. (A) “Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.”
(B) “Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.”
(iv) For products containing naphazoline hydrochloride identified in § 341.20(b)(6) at a concentration of 0.05 percent. “Do not use this product in children under 12 years of age because it may cause sedation if swallowed.”
(v) For products containing propylhexedrine identified in § 341.20(b)(9) when used in an inhalant dosage form and when labeled for adults. “Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.”
(vi) For products containing any topical nasal decongestant identified in § 341.20(b) when labeled for children under 12 years of age. The labeling of the product contains the warnings identified in paragraph (c)(2)(i) of this section.
(vii) For products containing levmetamfetamine identified in § 341.20(b)(1) when used in an inhalant dosage form and when labeled for children under 12 years of age. “Do not use this product for more than 7 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, ask a doctor.”
(viii) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, naphazoline hydrochloride, oxymetazoline hydrochloride, phenylephrine hydrochloride, or xylometazoline hydrochloride identified in § 341.20(b)(2), (b)(3), (b)(4), (b)(6), (b)(7), (b)(8), and (b)(10) when used as nasal sprays, drops, or jellies and when labeled for children under 12 years of age. (A) “Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.”
(B) “Do not use this product in a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.”
(ix) For products containing propylhexedrine identified in § 341.20(b)(9) when used in an inhalant dosage form and when labeled for children under 12 years of age. “Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.”
(x) For topical nasal decongestant products labeled for both adults and for children under 12 years of age. The labeling of the product contains the applicable warnings identified in paragraphs (c)(2)(i), (c)(2)(ii), (c)(2)(iii), and (c)(2)(v) of this section.
(d) Directions. The labeling of the product contains the following information under the heading “Directions”:
(1) Oral nasal decongestants - (i) For products containing phenylephrine hydrochloride identified in § 341.20(a)(1). Adults and children 12 years of age and over: 10 milligrams every 4 hours not to exceed 60 milligrams in 24 hours. Children 6 to under 12 years of age: 5 milligrams every 4 hours not to exceed 30 milligrams in 24 hours. Children 2 to under 6 years of age: 2.5 milligrams every 4 hours not to exceed 15 milligrams in 24 hours. Children under 2 years of age: consult a doctor.
(ii) For products containing pseudoephedrine hydrochloride or pseudoephedrine sulfate identified in § 341.20 (a)(2) and (a)(3). Adults and children 12 years of age and over: 60 milligrams every 4 to 6 hours not to exceed 240 milligrams in 24 hours. Children 6 to under 12 years of age: 30 milligrams every 4 to 6 hours not to exceed 120 milligrams in 24 hours. Children 2 to under 6 years of age: 15 milligrams every 4 to 6 hours not to exceed 60 milligrams in 24 hours. Children under 2 years of age: consult a doctor.
(iii) For products containing phenylephrine bitartrate identified in § 341.20(a)(4). Include information on the number of dosage units and the quantity of water the dosage units are to be dissolved in prior to administration as shown in the following table:
| Age 1 | Dose 1 |
|---|---|
| Adults and children 12 years of age and over | 15.6 milligrams every 4 hours not to exceed 62.4 milligrams in 24 hours |
| Children 6 to under 12 years of age | 7.8 milligrams every 4 hours not to exceed 31.2 milligrams in 24 hours |
| Children under 6 years of age | Ask a doctor |
1Headings are not required to appear in the product's labeling
(2) Topical nasal decongestants - (i) For products containing levmetamfetamine identified in § 341.20(b)(1) when used in an inhalant dosage form. The product delivers in each 800 milliliters of air 0.04 to 0.150 milligrams of levmetamfetamine. Adults: 2 inhalations in each nostril not more often than every 2 hours. Children 6 to under 12 years of age (with adult supervision): 1 inhalation in each nostril not more often than every 2 hours. Children under 6 years of age: ask a doctor.
(ii) For products containing ephedrine, ephedrine hydrochloride, or ephedrine sulfate identified in § 341.20(b) (2), (3), and (4) - (A) Nasal drops or sprays - For a 0.5-percent aqueous solution. Adults and children 12 years of age and over: 2 or 3 drops or sprays in each nostril not more often than every 4 hours. Children 6 to under 12 years of age (with adult supervision): 1 or 2 drops or sprays in each nostril not more often than every 4 hours. Children under 6 years of age: consult a doctor.
(B) Nasal jelly - For a 0.5-percent water-based jelly. Adults and children 6 to under 12 years of age (with adult supervision): place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 4 hours.
(iii) For products containing naphazoline hydrochloride identified in § 341.20(b)(6) - (A) Nasal drops or sprays - (1) For a 0.05-percent aqueous solution. Adults and children 12 years of age and over: 1 or 2 drops or sprays in each nostril not more often than every 6 hours. Do not give to children under 12 years of age unless directed by a doctor.
(2) For a 0.025-percent aqueous solution. Children 6 to under 12 years of age (with adult supervision): 1 or 2 drops or sprays in each nostril not more often than every 6 hours. Children under 6 years of age: consult a doctor.
(B) Nasal jelly - (1) For a 0.05-percent water-based jelly. Adults and children 12 years of age and over: place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 6 hours. Do not give to children under 12 years of age unless directed by a doctor.
(2) For a 0.025-percent water-based jelly. Children 6 to under 12 years of age (with adult supervision): place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 6 hours. Children under 6 years of age: consult a doctor.
(iv) For products containing oxymetazoline hydrochloride identified in § 341.20(b)(7) - (A) Nasal drops or sprays - (1) For a 0.05-percent aqueous solution. Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. Children under 6 years of age: consult a doctor.
(2) A 0.025-percent aqueous solution in a container having either a calibrated dropper or a metered-dose spray that delivers no more than 0.027 milligrams of oxymetazoline per three drops or three sprays. Children 2 to under 6 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 10 to 12 hours. Use only recommended amount. Do not exceed 2 doses in any 24-hour period. [previous two sentences in boldface type] Children under 2 years of age: consult a doctor.
(B) Nasal jelly - For a 0.05-percent water-based jelly. Adults and children 6 to under 12 years of age (with adult supervision): place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. Children under 6 years of age: consult a doctor.
(v) For products containing phenylephrine hydrochloride identified in § 341.20(b)(8) - (A) Nasal drops or sprays - (1) For a 1-percent aqueous solution. Adults and children 12 years of age and over: 2 or 3 drops or sprays in each nostril not more often than every 4 hours. Do not give to children under 12 years of age unless directed by a doctor.
(2) For a 0.5-percent aqueous solution. Adults and children 12 years of age and over: 2 or 3 drops or sprays in each nostril not more often than every 4 hours. Do not give to children under 12 years of age unless directed by a doctor.
(3) For a 0.25-percent aqueous solution. Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 4 hours. Children under 6 years of age: consult a doctor.
(4) A 0.125-percent aqueous solution in a container having either a calibrated dropper or a metered-dose spray that delivers no more than 0.135 milligrams of phenylephrine per three drops or three sprays. Children 2 to under 6 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 4 hours. Use only recommended amount. [previous sentence in boldface type] Children under 2 years of age: consult a doctor.
(B) Nasal jelly - (1) For a 1-percent water-based jelly. Adults and children 12 years of age and over: place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 4 hours. Do not give to children under 12 years of age unless directed by a doctor.
(2) For a 0.5-percent water-based jelly. Adults and children 12 years of age and over: place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 4 hours. Do not give to children under 12 years of age unless directed by a doctor.
(3) For a 0.25-percent water-based jelly. Adults and children 6 to under 12 years of age (with adult supervision): place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 4 hours. Children under 6 years of age: consult a doctor.
(vi) For products containing propylhexedrine identified in § 341.20(b)(9) when used in an inhalant dosage form. The product delivers in each 800 milliliters of air 0.40 to 0.50 milligrams of propylhexedrine. Adults and children 6 to under 12 years of age (with adult supervision): 2 inhalations in each nostril not more often than every 2 hours. Children under 6 years of age: consult a doctor.
(vii) For products containing xylometazoline hydrochloride identified in § 341.20(b)(10) - (A) Nasal drops or sprays - (1) For a 0.1-percent aqueous solution. Adults and children 12 years of age and over: 2 or 3 drops or sprays in each nostril not more often than every 8 to 10 hours. Do not give to children under 12 years of age unless directed by a doctor.
(2) A 0.05-percent aqueous solution in a container having either a calibrated dropper or a metered-dose spray that delivers no more than 0.054 milligrams of xylometazoline per three drops or three sprays. Children 6 to under 12 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 8 to 10 hours. Children 2 to under 6 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 8 to 10 hours. Use only recommended amount. Do not exceed 3 doses in any 24-hour period. [previous two sentences in boldface type] Children under 2 years of age: consult a doctor.
(B) Nasal jelly - (1) For a 0.1-percent water-based jelly. Adults and children 12 years of age and over: place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 8 to 10 hours. Do not give to children under 12 years of age unless directed by a doctor.
(2) For a 0.05-percent water-based jelly. Children 6 to under 12 years of age (with adult supervision): place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 8 to 10 hours. Children under 6 years of age: consult a doctor.
(viii) Other required statements - For products containing levmetamfetamine or propylhexedrine identified in § 341.20(b)(1) or (b)(9) when used in an inhalant dosage form. (A) “This inhaler is effective for a minimum of 3 months after first use.”
(B) “Keep inhaler tightly closed.”
The statements of identity, indications, warnings, and directions for use, respectively, applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable.
(a) Statement of identity. For a combination drug product that has an established name, the labeling of the product states the established name of the combination drug product, followed by the statement of identity for each ingredient in the combination, as established in the statement of identity sections of the applicable OTC drug monographs. If there is no established name, the labeling of the product states the statement of identity for each ingredient in the combination, as established in the statement of identity sections of the applicable OTC drug monographs, unless otherwise stated in this paragraph (a).
(1) For permitted combinations identified in § 341.40(a), (c), (f), (g), (l), (m), (n), (o), (q), and (r) containing an analgesic-antipyretic active ingredient. The analgesic-antipyretic component of the product shall be identified as a “pain reliever” or “analgesic (pain reliever).” If the product is also labeled to relieve fever, then the analgesic-antipyretic component is identified as a “pain reliever-fever reducer” or “analgesic (pain reliever)-antipyretic (fever reducer).”
(2) [Reserved]
(b) Indications. The labeling of the product states, under the heading “Uses,” the indication(s) for each ingredient in the combination, as established in the indications sections of the applicable OTC drug monographs, unless otherwise stated in this paragraph (b). Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in the applicable OTC drug monographs or listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.
(1) For permitted combinations containing an analgesic-antipyretic active ingredient identified in § 341.40(a), (c), (f). (g), (l), (m), (n), (o), (q), and (r) when labeled for relief of general cough-cold symptoms and/or the common cold. (i) The labeling for the analgesic-antipyretic ingredients states “[bullet] temporarily relieves [bullet] minor aches and pains [bullet] headache” and “[bullet] temporarily reduces fever”.
(ii) The labeling for the cough-cold ingredient(s) may follow a separate bullet(s) or may be combined with the relieves part of the indication in paragraph (b)(1)(i) of this section.
(2) For permitted combinations containing an analgesic-antipyretic active ingredient identified in § 341.40(a), (c), (f), (g), (m), (q), and (r) when labeled for relief of hay fever/allergic rhinitis and/or nasal congestion symptoms. (i) The labeling for the analgesic-antipyretic ingredients states “[bullet] temporarily relieves [bullet] minor aches and pains [bullet] headache”.
(ii) The indication(s) for the cough-cold ingredient(s) consists of the labeling for antihistamines in § 341.72(b)(1) or (b)(2) and/or nasal decongestants in § 341.80(b)(1)(ii), as appropriate, and the labeling for any other cough-cold combination. This labeling may follow a separate bullet(s) or may be combined with the indication in paragraph (b)(2)(i) of this section.
(3) For permitted combinations containing an oral analgesic-antipyretic active ingredient identified in § 341.40(a), (c), (f), (g), (m), (q), and (r) when labeled for relief of general cough-cold symptoms and/or the common cold and for relief of hay fever/allergic rhinitis and/or nasal congestion symptoms. The labeling states both indications in paragraphs (b)(1) and (b)(2) of this section.
(4) For permitted combinations containing an oral anesthetic-analgesic active ingredient identified in § 341.40(k), (s), (t), (z), (aa), and (bb). The labeling for the anesthetic-analgesic ingredients in part 356 of this chapter should be used.
(5) For permitted combinations containing camphor, menthol, and eucalyptus oil identified in § 341.40(u). The labeling for antitussive ingredients in § 341.74(b) should be used.
(6) For permitted combinations containing levmetamfetamine with aromatics identified in § 341.40(v). The labeling for nasal decongestant ingredients in § 341.80(b) should be used.
(7) Other allowable statements. In addition to the required information identified in paragraph (b) of this section, the labeling of the combination drug product may contain any of the “other allowable statements” (if any), that are identified in the applicable OTC drug monographs, provided such statements are neither placed in direct conjunction with information required to appear in the labeling nor occupy labeling space with greater prominence or conspicuousness than the required information.
(c) Warnings. The labeling of the product states, under the heading “Warnings,” the warning(s) for each ingredient in the combination, as established in the warnings sections of the applicable OTC drug monographs, unless otherwise stated in paragraph (c) of this section.
(1) For permitted combinations containing an antitussive and an analgesic-antipyretic identified in § 341.40(f), (g), (l), and (m). The labeling states the following warnings:
(i) For products labeled only for adults. The following warning should be used instead of the warnings in § 341.74(c)(1) and part 343 of this chapter: “Stop use and ask a doctor if [in bold type] [bullet] pain or cough gets worse or lasts more than 7 days [bullet] fever gets worse or lasts more than 3 days [bullet] redness or swelling is present [bullet] new symptoms occur [bullet] cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.”
(ii) For products labeled only for children under 12 years of age. The following warning should be used instead of the warnings in § 341.74(c)(3) and part 343 of this chapter: “Stop use and ask a doctor if [in bold type] [bullet] pain or cough gets worse or lasts more than 5 days [bullet] fever gets worse or lasts more than 3 days [bullet] redness or swelling is present [bullet] new symptoms occur [bullet] cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.”
(iii) For products labeled for both adults and for children under 12 years of age. The following warning should be used instead of the warnings in § 341.74(c)(2) and part 343 of this chapter: “Stop use and ask a doctor if [in bold type] [bullet] pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) [bullet] fever gets worse or lasts more than 3 days [bullet] redness or swelling is present [bullet] new symptoms occur [bullet] cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.”
(2) For permitted combinations containing an expectorant and an analgesic-antipyretic identified in § 341.40(o). The labeling states the following warnings:
(i) For products labeled only for adults. The warning in paragraph (c)(1)(i) of this section should be used instead of the warnings in § 341.78(c)(3) and part 343 of this chapter.
(ii) For products labeled only for children under 12 years of age. The warning in paragraph (c)(1)(ii) of this section should be used instead of the warnings in § 341.78(c)(3) and part 343 of this chapter.
(iii) For products labeled for both adults and for children under 12 years of age. The warning in paragraph (c)(1)(iii) of this section should be used instead of the warnings in § 341.78(c)(3) and part 343 of this chapter.
(3) For permitted combinations containing a nasal decongestant and an analgesic-antipyretic identified in § 341.40(c), (g), (m), (n), (q), and (r). The labeling states the following warnings:
(i) For products labeled only for adults. The following warning should be used instead of the warnings in § 341.80(c)(1)(i)(B) and part 343 of this chapter: “Stop use and ask a doctor if [in bold type] [bullet] pain or nasal congestion gets worse or lasts more than 7 days [bullet] fever gets worse or lasts more than 3 days [bullet] redness or swelling is present [bullet] new symptoms occur”.
(ii) For products labeled for only children under 12 years of age. The following warning should be used instead of the warnings in § 341.80(c)(1)(ii)(B) and part 343 of this chapter: “Stop use and ask a doctor if [in bold type] [bullet] pain or nasal congestion gets worse or lasts more than 5 days [bullet] fever gets worse or lasts more than 3 days [bullet] redness or swelling is present [bullet] new symptoms occur”.
(iii) For products labeled for both adults and children under 12 years of age. The following warning should be used instead of the warnings in § 341.80(c)(1)(iii) and part 343 of this chapter: “Stop use and ask a doctor if [in bold type] [bullet] pain or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) [bullet] fever gets worse or lasts more than 3 days [bullet] redness or swelling is present [bullet] new symptoms occur”.
(4) For permitted combinations containing an antihistamine combined with an oral antitussive. The labeling states the warning “When using this product [in bold type] [bullet] may cause marked drowsiness.” The word “marked” may be deleted from the warning upon petition under the provisions of § 10.30 of this chapter provided adequate data are submitted to demonstrate that the combination product does not cause a significant increase in drowsiness as compared with each active ingredient when tested alone. The petition and the data it contains will be maintained in a permanent file for public review in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
(5) For permitted combinations containing camphor, menthol, and eucalyptus oil identified in § 341.40(u). The labeling states the warnings for topical antitussive ingredients in § 341.74(c).
(6) For permitted combinations containing levmetamfetamine with aromatics identified in § 341.40(v). The labeling states the warnings for topical nasal decongestant ingredients in § 341.80(c)(2).
(d) Directions. The labeling of the product states, under the heading “Directions,” directions that conform to the directions established for each ingredient in the directions sections of the applicable OTC drug monographs, unless otherwise stated in paragraph (d) of this section. When the time intervals or age limitations for administration of the individual ingredients differ, the directions for the combination product may not exceed any maximum dosage limits established for the individual ingredients in the applicable OTC drug monograph.
(1) For permitted combinations containing an anesthetic/analgesic and/or a demulcent in a liquid dosage form identified in § 341.40(k), (s), (t), (w), (x), (y), (z), (aa), and (bb). The labeling states “[optional, bullet] gargle, swish around, or keep in the mouth for at least 1 minute and then swallow. Do not spit out.”
(2) For permitted combinations containing camphor, menthol, and eucalyptus oil identified in § 341.40(u). The labeling states the directions for topical antitussive ingredients in § 341.74(d).
(3) For permitted combinations containing levmetamfetamine with aromatics identified in § 341.40(v). The labeling states the directions for topical nasal decongestant ingredients in § 341.80(d)(2)(i) and (d)(2)(viii).
The labeling of the product provided to health professionals (but not to the general public) may contain the following additional dosage information for products containing the active ingredients identified below:
(a) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, or racephedrine hydrochloride identified in § 341.16 (a), (b), (c), and (f). Children 6 to under 12 years of age: oral dosage is 6.25 to 12.5 milligrams every 4 hours, not to exceed 75 milligrams in 24 hours. Children 2 to under 6 years of age: oral dosage is 0.3 to 0.5 milligram per kilogram of body weight every 4 hours, not to exceed 2 milligrams per kilogram of body weight in 24 hours.
(b) For products containing chlophedianol hydrochloride identified in 341.14(a)(1). Children 2 to under 6 years of age: oral dosage is 12.5 milligrams every 6 to 8 hours, not to exceed 50 milligrams in 24 hours.
(c) For products containing codeine ingredients identified in § 341.14(a)(2). (1) Children 2 to under 6 years of age: Oral dosage is 1 milligram per kilogram body weight per day administered in four equal divided doses. The average body weight for each age may also be used to determine dosage as follows: For children 2 years of age (average body weight, 12 kilograms), the oral dosage is 3 milligrams every 4 to 6 hours, not to exceed 12 milligrams in 24 hours; for children 3 years of age (average body weight, 14 kilograms), the oral dosage is 3.5 milligrams every 4 to 6 hours, not to exceed 14 milligrams in 24 hours; for children 4 years of age (average body weight, 16 kilograms), the oral dosage is 4 milligrams every 4 to 6 hours, not to exceed 16 milligrams in 24 hours: for children 5 years of age (average body weight, 18 kilograms), the oral dosage is 4.5 milligrams every 4 to 6 hours, not to exceed 18 milligrams in 24 hours. The manufacturer must relate these dosages for its specific product dosages for its specific product to the use of the calibrated measuring device discussed in paragraph (c)(3) of this section. If age is used to determine the dose, the directions must include instructions to reduce the dose for low-weight children.
(2) Parents should be instructed to obtain and use a calibrated measuring device for administering the drug to the child, to use extreme care in measuring the dosage, and not exceed the recommended daily dosage.
(3) A dispensing device (such as a dropper calibrated for age or weight) should be dispensed along with the product when it is intended for use in children 2 to under 6 years of age to prevent possible overdose due to improper measuring of the dose.
(4) Codeine is not recommended for use in children under 2 years of age. Children under 2 years may be more susceptible to the respiratory depressant effects of codeine, including respiratory arrest, coma, and death.
(d) The following labeling indication may be used for products containing guaifenesin identified in § 341.18 when used as a single ingredient product. “Helps loosen phlegm and thin bronchial secretions in patients with stable chronic bronchitis.”
(e) For products containing brompheniramine maleate identified in § 341.12(a). Children 2 to under 6 years of age: oral dosage is 1 milligram every 4 to 6 hours, not to exceed 6 milligrams in 24 hours.
(f) For products containing chlorcyclizine hydrochloride identified in § 341.12(b). Children 6 to under 12 years of age: oral dosage is 12.5 milligrams every 6 to 8 hours, not to exceed 37.5 milligrams in 24 hours. Children 2 to under 6 years of age: oral dosage is 6.25 milligrams every 6 to 8 hours, not to exceed 18.75 milligrams in 24 hours.
(g) For products containing chlorpheniramine maleate identified in § 341.12(c). Children 2 to under 6 years of age: oral dosage is 1 milligram every 4 to 6 hours, not to exceed 6 milligrams in 24 hours.
(h) For products containing dexbrompheniramine maleate identified in § 341.12(d). Children 2 to under 6 years of age: oral dosage is 0.5 milligram every 4 to 6 hours, not to exceed 3 milligrams in 24 hours.
(i) For products containing dexchlorpheniramine maleate identified in § 341.12(e). Children 2 to under 6 years: oral dosage is 0.5 milligram every 4 to 6 hours, not to exceed 3 milligrams in 24 hours.
(j) For products containing diphenhydramine citrate identified in § 341.12(f). Children 2 to under 6 years of age: oral dosage is 9.5 milligrams every 4 to 6 hours, not to exceed 57 milligrams in 24 hours.
(k) For products containing diphenhydramine hydrochloride identified in § 341.12(g). Children 2 to under 6 years of age: oral dosage is 6.25 milligrams every 4 to 6 hours, not to exceed 37.5 mg in 24 hours.
(l) For products containing doxylamine succinate identified in § 341.12(h). Children 2 to under 6 years of age: oral dosage is 1.9 to 3.125 milligrams every 4 to 6 hours, not to exceed 18.75 milligrams in 24 hours.
(m) For products containing phenindamine tartrate identified in § 341.12(i). Children 2 to under 6 years of age: oral dosage is 6.25 milligrams every 4 to 6 hours, not to exceed 37.5 milligrams in 24 hours.
(n) For products containing pheniramine maleate identified in § 341.12(j). Children 2 to under 6 years of age: oral dosage is 3.125 to 6.25 milligrams every 4 to 6 hours, not to exceed 37.5 milligrams in 24 hours.
(o) For products containing pyrilamine maleate identified in § 341.12(k). Children 2 to under 6 years of age: oral dosage is 6.25 to 12.5 milligrams every 6 to 8 hours, not to exceed 50 milligrams in 24 hours.
(p) For products containing thonzylamine hydrochloride identified in § 341.12(l). Children 2 to under 6 years of age: oral dosage is 12.5 to 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours.
(q) For products containing triprolidine hydrochloride identified in § 341.12(m). Children 4 to under 6 years of age: oral dosage is 0.938 milligram every 4 to 6 hours, not to exceed 3.744 milligrams in 24 hours. Children 2 to under 4 years of age: oral dosage is 0.625 milligram every 4 to 6 hours, not to exceed 2.5 milligrams in 24 hours. Infants 4 months to under 2 years of age: oral dosage is 0.313 milligram every 4 to 6 hours, not to exceed 1.252 milligrams in 24 hours.
(r) For products containing diphenhydramine citrate identified in § 341.14(a)(5). Children 2 to under 6 years of age: oral dosage is 9.5 milligrams every 4 hours, not to exceed 57 milligrams in 24 hours.
(s) For products containing diphenhydramine hydrochloride identified in § 341.14(a)(6). Children 2 to under 6 years of age: oral dosage is 6.25 milligrams every 4 hours, not to exceed 37.5 milligrams in 24 hours.