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FDA Guidance for Industry: Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use



This guidance is intended to inform manufacturers of certain nonprescription (also referred to as over-the-counter or (OTC)) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products that contain acetaminophen of the circumstances in which FDA does not intend to object to the inclusion of a liver warning that differs from that required under § 201.326(a)(1)(iii)(A) and § 201.326(a)(1)(v)(A) (21 CFR 201.326(a)(1)(iii)(A) and 21 CFR 201.326(a)(1)(v)(A)), provided the warning appears as described below.

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