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Guidance on Labeling for Drugs Containing Acetaminophen


Federal Register Notice: FDA is making available a guidance for industry entitled Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use--Labeling for Products That Contain Acetaminophen. It is intended to inform manufacturers of certain nonprescription internal analgesic, antipyretic, and antirheumatic drug products that contain acetaminophen about the circumstances for which FDA does not intend to object to the inclusion of a liver warning that differs from that required under FDA regulations, provided the warning appears as described in the guidance. To download this guidance, click here. To view this notice, click here.