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FDA says acetaminophen doses over 325 mg in combo drugs could damage liver

Prescription combination drugs with over 325 mg of acetaminophen could cause liver damage, according to a Jan. 14, 2014 Food and Drug Administration press statement.

The Food and Drug Administration recommends prescription combination drugs should contain no more than 325 mg of acetaminophen to avoid liver damage.
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CNN reports the government agency is recommending health care professionals stop prescribing combination medications – those made up of two or more drugs – that contain over 325 mg of acetaminophen per dosage.

Unintentional overdoses from combination drugs containing acetaminophen are responsible for almost half of “all cases of acetaminophen-related liver failure in the United States,” NBC News reports the FDA said in its statement.

The FDA noted, “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 CNN.

The warning is not applicable to over-the-counter drugs that contain acetaminophen.

NBC reports that in Jan. 2011, the FDA requested makers of combination medications to limit acetaminophen doses to 325 mg or less per tablet or capsule by Jan. 14, 2014.

According to CNN, acetaminophen is often times combined with “opioids such as oxycodone (Percocet), hydrocodone (Vicodin) and codeine (Tylenol with Codeine).”

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