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# Guidance on OTC Acetaminophen Product Skin Reaction Warnings
- URL: https://www.fdaweb.com/guidance-on-otc-acetaminophen-product-skin-reaction-warnings/
- Published: 2017-01-10T12:00:00.000Z
- Updated: 2026-09-14T21:59:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137681

FDA has released a guidance on “Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions.” The guidance is based on a 2013 drug safety alert that warned about the use of acetaminophen and its association with rare but serious skin reactions. These skin reactions, including Stevens-Johnson Syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis, can be fatal, according to the agency. The document also informs manufacturers that at this time FDA does not intend to take action against the marketing of single-and combination-ingredient, acetaminophen-containing, nonprescription drug products bearing a recommended warning as described in the guidance.