Over-the-Counter Drug Products Containing Analgesic/Antipyretic Active Ingredients for Internal Use; Required Alcohol Warning; Final Rule; Compliance Date

Riepilogo

The Food and Drug Administration (FDA) is establishing a compliance date of October 22, 1999, for the regulation that published in the Federal Register of October 23, 1998 (63 FR 56789). The regulation established warning statements that advise consumers with a history of heavy alcohol use to consult a physician for advice about the use of OTC internal analgesic/antipyretic drug products. The compliance date applies to all affected OTC drug products, whether marketed with or without an approved application. FDA is taking this action in response to correspondence and a citizen petition requesting more time to relabel these products.