Requests that the FDA require revisions to the labeling for all over-the-counter acetaminophen-containing drug products marketed under the Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use monograph (OTC Monograph M013): (i) a revision to the “Warnings” subsection, currently found at M013.50(c)(1)(iii) in the Labeling section.
🏛 Food and Drug Administration (FDA)FDA-2025-P-4153
Documents
1
Total comments
315
1 awaiting analysis
Comment status
Open
Last activity
Jun 27, 2026
In this docket
Documents
Rules, notices, and supporting material — the primary rule pinned first.
- Other· Sep 25, 2025No comment period💬 315
