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Acetaminophen and ibuprofen

When sold 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*
*Note that this listing does not apply to products containing ibuprofen that would meet the criteria to be included on the Prescription Drug list, as these would require a prescription

Approval Date:

Schedule: II