Code of Federal Regulations (Last Updated: July 5, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter D - Drugs for Human Use |
Part 338 - Nighttime Sleep-Aid Drug Products for over-the-Counter Human Use |
Subpart B - Active Ingredients |
§ 338.10 - Nighttime sleep-aid active ingredients.
Latest version.
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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.