Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Overth

• Date: November 04, 2009
• Source: www.fda.gov

The Food and Drug Administration (FDA) is issuing this final rule to require 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 antiinflammatory drugs (NSAIDS). The new labeling is required for all OTC IAAA drug products whether marketed under an OTC drug monograph or an approved new drug application (NDA).

Effective Date: This final rule is effective April 29, 2010

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