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FDA: Don’t provide drugs with more than 325 mg acetaminophen


The Food and Drug Administration has recommended that healthcare professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams of acetaminophen per tablet, capsule or other dosage unit.

There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury, according to an FDA statement.

Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant and death.

“We recommend that healthcare providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen,” the FDA wrote. “We also recommend 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, the FDA stated. In that case, the total dose of acetaminophen would be 650 mg. When making individual dosing determinations, healthcare providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product.

FDA Alert:


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