Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph, and Related Labeling

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The Food and Drug Administration (FDA) is proposing to amend the tentative final monograph (TFM) for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products to include ibuprofen as a generally recognized safe and effective analgesic/antipyretic active ingredient for OTC use. FDA is also proposing to amend its regulations to include consistent allergy warnings for OTC IAAA drug products containing nonsteroidal anti- inflammatory active ingredients. These proposals are in response to a citizen petition (Ref. 1) and to a comment submitted in response to that petition (Ref. 2) and are part of the ongoing review of OTC drug products conducted by FDA.