e-CFR data is current as of January 14, 2021 |
Title 21 → Chapter I → Subchapter D → Part 338 → Subpart B |
Title 21: Food and Drugs
PART 338—NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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.