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

Résumé

The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking that would establish alcohol warnings for all over- the-counter (OTC) drug products containing internal analgesic/ antipyretic active ingredients labeled for adult use. The proposed warning statements advise consumers who have a history of heavy alcohol use or abuse to consult a physician for advice about the use of OTC internal analgesic/antipyretic drug products. A warning would be required for all OTC internal analgesic/antipyretic drug products marketed under an OTC drug monograph or an approved new drug application (NDA). FDA is issuing this notice of proposed rulemaking after considering the reports and recommendations of its Nonprescription Drugs Advisory Committee (NDAC) and Arthritis Drugs Advisory Committee (ADAC), public comments on the proposed rule for OTC internal analgesic, antipyretic, and antirheumatic drug products, and other available information.