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

Resumen

The Food and Drug Administration (FDA) is proposing to amend the tentative final monograph for over-the-counter (OTC) external analgesic drug products, and the final monographs for oral OTC diphenhydramine drug products for antiemetic, antihistamine, antitussive, and nighttime sleep-aid indications. The amendment adds warning statements concerning diphenhydramine toxicity. The proposed warnings advise consumers not to use topical products containing diphenhydramine on chicken pox, poison ivy, sunburn, large areas of the body, blistered or oozing skin, more often than directed, or with any other product containing diphenhydramine, even one taken by mouth, and not to use oral OTC diphenhydramine products with any other product containing diphenhydramine including products used topically. This proposal is part of the ongoing review of OTC drug products conducted by FDA.