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FDA Recommendation for Acetaminophen

Do not prescribe and dispense combination drug products that contain more than 325 milligrams (mg) of acetaminophen: FDA recommendation

The USFDA has now (as reported on 01/14/2014) recommended discontinuing prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit to avoid liver damage. The FDA also recommends that “when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit that they contact the prescriber to discuss a product with a lower dose of acetaminophen. A two tablet or two capsule dose may still be prescribed, if appropriate. In that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units). When making individual dosing determinations, health care providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product.”

Acetaminophen is one of the most common over-the-counter (OTC) pain and fever medications available. It is also often combined with other easily available OTC products such as those used for cough and cold. Although most manufacturers have complied with the FDA recommendation, some still remain available in the market.

More information is available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma....