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National Drug Schedules: Final Recommendations for acetaminophen and ibuprofen combination tablets

National Drug Schedule

The interim recommendations made by the National Drug Scheduling Advisory Committee (NDSAC) on June 26, 2020 that:

  • Acetaminophen and ibuprofen in oral, fixed-dose combinations, in package sizes containing 20,000 mg or less of acetaminophen and 6,000 mg or less of ibuprofen, be granted Schedule III status; and
  • Acetaminophen and ibuprofen in oral, fixed-dose combinations, in package sizes containing either more than 20,000 mg of acetaminophen or more than 6,000 mg of ibuprofen, be granted Schedule II status;

were finalized effective July 28, 2020. Final approval of the interim recommendations was made by NAPRA’s Board of Directors, in consideration of comments received during the 30-day review period. The National Drug Schedules will be revised accordingly.

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