21 CFR § 338.10 Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use

§ 338.10 Nighttime sleep-aid active ingredients.

Current through Sep 8, 2026 · Read all of Part 338

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.

← § 338.3 Definition.§ 338.50 Labeling of nighttime sleep-aid drug products. →