21 C.F.R. § 338.10   Nighttime sleep-aid active ingredients.


Title 21 - Food and Drugs


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.

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.
























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