U.S. Food and Drug Administration

Order Title: Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use

Summary

FDA is issuing this proposed administrative order to amend the requirements for internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter (OTC) human use, as currently described in Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use (OTC Monograph M013). This proposed order, if finalized, will amend OTC Monograph M013 to require the addition of a warning to the labeling of OTC internal analgesic, antipyretic, and antirheumatic drug products containing acetaminophen. The warning would alert consumers that the use of acetaminophen may cause severe skin reactions. NOTE: Due to technical difficulties, comments on this proposed order cannot be submitted in the OTC Monographs@FDA portal. Submit comments on this proposed order [OTC000035] electronically in docket number FDA-2024-N-2422 in the Federal eRulemaking Portal at https://www.regulations.gov. FDA is reopening the comment period for this proposed order. Comments will be accepted at any time until 11:59 pm Eastern Time at the end of September 27, 2024. Otherwise, the instructions in the proposed order for submitting comments remain applicable. The Scientific Review Supporting Proposed Administrative Order OTC000035 can be viewed under the Supporting Documents.

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