Labeling of Diphenhydramine-Containing Drug Products for Over-the-Counter Human Use

The Food and Drug Administration (FDA) is issuing a final rule amending the final monographs for over-the-counter (OTC) antiemetic, antihistamine, antitussive, and nighttime sleep-aid drug products to add a warning statement for oral products containing diphenhydramine citrate or diphenhydramine hydrochloride. The warning advises consumers not to use oral OTC diphenhydramine products with any other product containing diphenhydramine, including products used topically. This final rule also includes the agency's conclusions on additional warning statements and a direction statement for OTC external analgesic drug products containing diphenhydramine hydrochloride. These conclusions will be incorporated into the final monograph for OTC external analgesic drug products in a future issue of the Federal Register. FDA is issuing this final rule after considering public comments on the agency's proposed regulation and all new data and information on drug products containing diphenhydramine that have come to the agency's attention.