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GUIDANCE DOCUMENT

Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Guidance for Industry November 2015

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2012-D-0529
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to help small businesses understand and comply with FDA’s organ-specific labeling regulation for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products. The regulation requires IAAA manufacturers to label their products with specific warnings and related information to alert consumers about potential liver injury and stomach bleeding associated with IAAA drug products. Manufacturers must be in compliance with the final rule beginning on April 29, 2010. The Food and Drug Administration (FDA) has prepared this guidance in accordance with section 212 of the Small Business Regulatory Fairness Act (Public Law 104-121).

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2012-D-0529.

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