According to the agency, there is no data that shows taking more than 325 mg of acetaminophen per dosage unit provides additional benefits that outweigh the risk for liver injury. They also note that limiting the amount of acetaminophen consumed will reduce the risk of severe liver injury from inadvertent overdose, which can lead to liver failure, liver transplant and death.
The FDA is recommending the following:
- That healthcare providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen
- That pharmacists call prescribers to discuss a product with a lower dosage of acetaminophen when they receive a prescription containing more than 325 mg of acetaminophen
- That prescribers always consider the amounts of both acetaminophen and opioid components when making individual dosing determinations
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