Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph
fda-drug · Food and Drug Administration · Rule · Published 2009-04-29 · Effective 2010-04-29 · 74 FR 19385
Document
Document number
E9-9684
Federal Register citation
74 FR 19385
CFR reference
21 CFR 201
Type
Rule
Action
Final rule.
Category
fda-drug
Sub-agency
Food and Drug Administration
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).