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Final Monograph - Organ-Specific Warnings - Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library

Final Monograph - Organ-Specific Warnings - Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Final Monograph - Organ-Specific Warnings - Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 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 anti-inflammatory 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). This book contains: - The complete text of the Final Monograph - Organ-Specific Warnings - Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section