Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 5 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER D - DRUGS FOR HUMAN USE
/ PART 338 - NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
/ Subpart B - Active Ingredients
Subpart B - Active Ingredients
§ 338.10 Nighttime sleep-aid active ingredients.
The active ingredient of the product consists of any of the following when used within the dosage limits established for each ingredient in § 338.50(d):
(a) Diphenhydramine hydrochloride.
(b) Diphenhydramine citrate.