New Manufacturers' Labeling Requirements for OTC Products Containing Diphenhydramine

Concern for the potential for additive side effects from concomitant use of more than one nonprescription medication containing diphenhydramine prompted the FDA to recommend changes in labeling. The change applies to oral antiemetic, antihistamine, antitussive and nighttime sleep aid drug products containing diphenhydramine citrate or diphenhydramine hydrochloride. The warning statement that will be added to labels recommends to consumers that if they are taking a medication containing diphenhydramine they should avoid taking additional medications that also contain diphenhydramine, including topical products. This rule is effective December 8, 2003. For complete information please refer to Federal Register: December 6, 2002 (Volume 67 Number 2351). Return to Top