The FDA says prescription drugs with more than 325 milligrams of acetaminophen could cause liver damage.
The agency also says there's nothing that indicates that the benefits of taking more than 325 milligrams outweighs the risks for liver injury.
Acetaminophen is often used in combination with painkillers, such as oxycodone, hydrocodone and codeine. The warning does not apply to over-the-counter drugs, such as Tylenol. Tylenol contains acetaminophen. But the FDA says it plans on addressing over-the-counter acetaminophen products in another regulatory action.