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

Résumé

The Food and Drug Administration (FDA) is proposing to amend its over-the-counter (OTC) labeling regulations and the tentative final monograph (TFM) for OTC internal analgesic, antipyretic, and antirheumatic (IAAA) drug products to include new warnings and other labeling requirements advising consumers about potential risks and when to consult a doctor. FDA is also proposing to remove the alcohol warning in its regulations and add new warnings and other labeling for all OTC IAAA drug products. The new labeling would be required for all OTC drug products containing an IAAA active ingredient whether marketed under an OTC drug monograph or an approved new drug application (NDA). FDA is issuing this proposal as part of its ongoing review of OTC drug products after considering the advice of its Nonprescription Drugs Advisory Committee (NDAC) and other available information. FDA is proposing these labeling changes because it has tentatively concluded they are necessary for these ingredients to be considered generally recognized as safe and effective and not misbranded for OTC use. FDA will address information about the cardiovascular risks of nonsteroidal anti-inflammatory drugs (NSAIDs)