United States of America. The Food and Drug Administration has proposed to amend the tentative final monograph for over-the-counter (OTC) diphenhydramine drug products for topical use as external analgesics and oral drug products for antiemetic, antihistamine, antitussive and night-time sleep aid indications. The amendment adds warning statements concerning diphenhydramine toxicity and advises patients:
. not to use topical OTC 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;
. not to use oral OTC products containing diphenhydramine with any other product containing diphenhydramine, including products used topically.
Reference: Federal Register 62(168): 45767-74 (1997).