eCFR - Qualomics

Keyword

Search in sections (Example, from 802)

Volume

Find

Product Classification

Title 21: Food and Drugs

« Home / Title 21 - Food and Drugs--Volume 6 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS / PART 522 - IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS / § 522.2615 Tripelennamine.

§ 522.2615 Tripelennamine.

(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) of tripelennamine hydrochloride.

(b) Sponsors. See Nos. 016592 and 051031 in § 510.600(c) of this chapter.

(d) Conditions of use - (1) Dogs and cats - (i) Amount. Administer 0.5 mg per pound of body weight by intramuscular injection.

(ii) Indications for use. For use in treating conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Horses - (i) Amount. Administer 0.5 mg per pound of body weight by intramuscular injection.

(ii) Indications for use. For use in treating conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3) Cattle - (i) Amount. Administer 0.5 mg per pound of body weight by intravenous or intramuscular injection.

(ii) Indications for use. For use in treating conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease.

(iii) Limitations. Treated cattle must not be slaughtered for food during treatment and for 4 days following the last treatment. Milk that has been taken during treatment and for 24 hours (two milkings) after the last treatment must not be used for food. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[51 FR 44450, Dec. 10, 1986, as amended at 61 FR 29480, June 11, 1996; 62 FR 4164, Jan. 29, 1997; 78 FR 17597, Mar. 22, 2013; 79 FR 16198, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; 82 FR 11508, Feb. 24, 2017]