Acetaminophen Warning: FDA Says Limit Dose to 325 MG

By: Erika Watts - January 17, 2014

The Food and Drug Administration (FDA) issued an acetaminophen warning on Tuesday and recommends that healthcare professionals stop prescribing drugs that contain more than 325 milligrams of acetaminophen. Acetaminophen is a pain medicine that you may recognize from taking Tylenol. The FDA says that prescribing more than 325 mg of acetaminophen per dosage unit can put people at risk for liver injury.

Many people may not realize it, but a number of prescription and over-the-counter drugs contain acetaminophen. According to a statement released by the FDA at the beginning of the cold and flu season, “more than 600 medications, both prescription and over-the-counter (OTC), contain the active ingredient acetaminophen to help relieve pain and reduce fever.” For example, oxycodone (Percocet), hydrocodone (Vicodin) and codeine are combination drugs that contain acetaminophen. Sometimes these drugs may contain more than 325 mg of acetaminophen, which prompted the FDA to issue a warning.

“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,” the warning read.

Since people often don’t realize that these combination drugs contain acetaminophen, they sometimes combine them with OTC drugs such as Tylenol or cold medications that contain acetaminophen. “Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much,” the FDA said.

This acetaminophen warning is nothing new. In 2011, the FDA asked manufacturers to stop producing combination prescription drugs that contain more than 325 mg of acetaminophen. At the time of the current warning, the FDA notes that more than half of manufacturers have complied with the request. Since some manufacturers are still producing these pills three years later, the FDA now plans to begin working on withdrawing approval for medications containing more than the recommended level of acetaminophen because of the possible health risks.

The FDA plans to address the current recommended acetaminophen dosage for Tylenol and other OTC drugs in another regulatory action. The maximum daily amount of acetaminophen is 4000 mg, which may be taken in 1000 mg doses in products such as Extra Strength Tylenol. Since the FDA now advises against prescribing combo drugs that contain more than 325 mg of acetaminophen, it will be interesting to see if the FDA decides to reduce the current OTC dosage in the forthcoming regulatory action.

Check out the FDA’s video acetaminophen warning below.

Image via YouTube

About the Author

Erika WattsErika Watts is a former teacher, now stay-at-home-mom and contributing writer for WebProNews. When she isn’t busy navigating parenthood and writing, she enjoys watching college sports and reading. Follow Erika on Twitter @erikawatts83, Pinterest or

View all posts by Erika Watts
  • http://webpronews b gueldoff

    The drug addicts can eat lots of those perks….easy 20 a day so ya, that’s a lot of tylenol..way over limit and no sense having addicts that end up needing liver transplants too right?

  • http://yahoo mary

    People are over medicated nowadays and the medical professionals do not review on a regular basis what the patient is taking ( yes there are some who review , but not all ) medical schooling needs a review and the education of doctors and nurses should be top notch .
    The general public needs to be educated on the dangers of self medicating .

  • Debbie

    I have been taking Hydrocodone or almost 20 yers and my liver is just fine !! Now because SOME people cannot use their prescribed nmedications as they are supposed to , I cannot get mine. I am sooo ticked ff. I cannot take arthritis meds because of probems with my kidneys. This is a bunch of C rap. Addicts will get it anyway and they eat it like candy….does the government think normal people are that stupid that the cannot read the directons or the side effects postd nt bottle ?

  • ??? ann fleming