In 1999, the FDA approved dosing instructions for children under 2 on pediatric ibuprofen products, including McNeil's Motrin, but rejected an advisory committee's recommendation to add comparable instructions to pediatric acetaminophen products.
Sources
- Dose of Confusion (propublica.org)
- https://www.chpa.org/sites/default/files/media/docs/2020-10/Briefing-Book-Pediatric-Acetaminophen-05172011.pdf (chpa.org)
- https://www.raps.org/resource/group-to-fda-use-enforcement-discretion-to-allow.html (raps.org)
- https://www.raps.org/resource/fda-recommendations-aim-to-make-liquid-acetaminoph.html (raps.org)
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019842s019lbl.pdf (accessdata.fda.gov)