# Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph
> **Food and Drug Administration** · Final rule. · Published 2009-04-29 · Effective 2010-04-29 · 74 FR 19385
## Document
- **Document number:** E9-9684
- **Category:** fda-drug
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 74 FR 19385
- **CFR reference:** 21 CFR 201
- **Publication date:** 2009-04-29
- **Effective date:** 2010-04-29
- **HHS docket:** Docket No. FDA-1977-N-0013
## Abstract

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).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2009/04/29/E9-9684/organ-specific-warnings-internal-analgesic-antipyretic-and-antirheumatic-drug-products-for)
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