Regulations last checked for updates: Nov 25, 2024

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

source: 54 FR 6826, Feb. 14, 1989, unless otherwise noted.
cite as: 21 CFR 338.10