FDA is informing manufacturers, members of the medical and scientific community, and other
interested persons that at this time we do not intend to take action against the marketing of singleand
combination-ingredient, acetaminophen-containing, nonprescription (commonly referred to
as over-the-counter (OTC)) drug products bearing an allergy warning as described in this
guidance (see section III, Discussion and Policy) alerting consumers that the use of
acetaminophen may cause severe skin reactions. This guidance is intended to apply to singleand
combination-ingredient acetaminophen-containing products marketed under the Tentative
Final Monograph (TFM) for Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) Drug
Products for Over-the-Counter Human Use, published in the Federal Register (53 FR 46204,
November 16, 1988).



Posted on the FDA website on 10 January 2017