Code of Federal Regulations · Section
§ 338.10 — Nighttime Sleep-aid Active Ingredients
21 C.F.R. § 338.10
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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.
Authorizing Statute
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Definitions; generally21 U.S.C. § 321