21 CFR 338.10 - Nighttime sleep-aid active ingredients.

Regulations last checked for updates: Nov 25, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024

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§ 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.

authority: 21 U.S.C. 321,351,352,353,355,360,371

source: 54 FR 6826, Feb. 14, 1989, unless otherwise noted.

cite as: 21 CFR 338.10