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FDA Warning: Acetaminophen Max 325mg per Rx

FDA Warning: Acetaminophen Max 325mg per Rx

The Food and Drug Administration (FDA) is recommending providers discontinue prescribing and dispensing prescription combo drug products that contain > 325 mg of acetaminophen (APAP) per tablet, capsule or other dosage unit. There are no available data to show that taking >325 mg of APAP per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of APAP per dosage unit will reduce the risk of severe liver injury from inadvertent APAP overdose, which can lead to liver failure, liver transplant, and death.

In January 2011 the FDA asked manufacturers of Rx APAP-containing combo drug products to limit APAP to ? 325 mg in each tablet or capsule by January 14, 2014. More than half of manufacturers have voluntarily complied with this request. However, some prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit remain available. The FDA intends to withdraw approval of Rx combination drug products containing > 325 mg APAP per dosage unit that remain on the market. To see the FDA alert, click here