Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment

The Food and Drug Administration (FDA) is amending a final rule that appeared in the Federal Register of April 29, 2009 (74 FR 19385) (as amended in the Federal Register of June 30, 2009 (74 FR 31177). The final rule requires important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal anti-inflammatory drugs (NSAIDs). This document is intended to clarify some provisions in the final rule which may be unclear. Specifically, this document addresses how blister cards can be labeled to comply with the new required labeling, clarifies the length of time that the "See new warnings" flag is required to appear in the labeling, and provides some optional wording to clarify the liver injury warning on OTC acetaminophen products containing multiple active ingredients.