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Industry Guidance Includes Latest Warning Information for OTC Analgesics, Antipyretics, and Antirheumatics
FDA released a Guidance for Industry, “Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use – Small Entity Compliance Guide” (PDF) on August 17, 2010 to help small businesses understand and comply with FDA’s organ-specific labeling regulation for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic drug products. As of April 29, 2010 manufacturers producing these products are required to label their products with specific warnings and related information about the risks of potential liver injury and stomach bleeding associated with these OTC drug products. For more information on related regulations, see the FDA Rulemaking History for OTC Internal Analgesic Drug Products Web page.
