FDA limits amount of acetaminophen

Jan. 14, 2011 at 1:04 PM
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WASHINGTON, Jan. 14 (UPI) -- U.S. government officials say they are asking drug manufacturers to limit the amount of acetaminophen used in prescription drug products.

The U.S. Food and Drug Administration is asking drug manufacturers to limit the strength of acetaminophen to 325 milligrams per tablet, capsule or other dosage unit used in prescription drugs, often in combination with opioids such hydrocodone with acetaminophen -- Vicodin or Lortab -- and oxycodone with acetaminophen -- Tylox or Percocet.

The FDA is also asking drug manufacturers to add a boxed warning to the label of all prescription drug products that contain acetaminophen giving information on the potential risk of severe liver injury and the potential risk for allergic reactions such as swelling of the face, mouth and throat; difficulty breathing, and itching or rash.

However, over-the-counter products containing acetaminophen such as Tylenol are not involved in this action and information about the potential for liver damage is already required, FDA officials said.

"Acetaminophen-containing prescription products are safe and effective when used as directed, though all medications carry some risks and do not stop taking your prescription pain medicine unless told to do so by your healthcare professional," the FDA says in a statement.

"Do not take more than one product that contains acetaminophen at any given time, do not take more of an acetaminophen-containing medicine than directed and do not drink alcohol when taking medicines that contain acetaminophen."

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