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

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The Food and Drug Administration (FDA) is proposing to amend the tentative final monograph for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic drug products to include the use of aspirin, buffered aspirin, and aspirin in combination with antacid to reduce the risk of vascular mortality in people with a suspected acute myocardial infarction (MI). This proposal is in response to two citizen petitions and is part of the ongoing review of OTC drug products conducted by FDA.