21 C.F.R. Subpart B—Active Ingredients
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 338—NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart B—Active Ingredients
§ 338.10 Nighttime sleep-aid active ingredients.
