FDA Tylenol Warning Limits Acetaminophen Dosage in Prescription Drugs

Whitney Taylor | January 20th, 2014

FDA Tylenol Warning - New York Medical Malpractice AttorneysAn FDA Tylenol warning limiting the amount of acetaminophen in prescription medications is now in effect, and the agency will begin to hold noncompliant companies accountable. In 2011, the FDA asked drug manufacturers to limit the amount of acetaminophen in drug combinations to 325 mg. Compliance was to go into effect in January, 2014, although about half of all drug manufacturers are still adding too much of the pain medication to their formulas.

Findings show acetaminophen overdose can lead to liver failure

The FDA made their request after studies showed acetaminophen dosing amounts over 325 mg. do not provide additional benefit in terms of pain management. However, that amount of the drug could significantly increase the user’s odds for liver damage. An overdose of the medication could even lead to liver failure or death in some circumstances.

According to the National Institutes of Health, overdoses of acetaminophen are one of the most common types of poisonings that occur around the globe. To further complicate the problem, prescription opioids like Vicodin and Percocet may also contain amounts of acetaminophen in their formulas. If the patient is unaware of this addition, they are at risk for taking more of the pain medication than is safe for them. For example, a patient may take over-the-counter acetaminophen tablets simultaneously with the prescription drug if the prescription is not sufficiently managing the pain.

The FDA has recommended that individuals take no more than 4,000 mg. of acetaminophen daily. While this may seem like a large amount, a single gel tablet of Extra Strength Tylenol contains 500 mg. When you combine that amount with dosing instructions that allow for repeat doses of 1,000 mg. every six hours, it is easy to see how someone could come dangerously close to that limit. This is especially true if the person is unaware there is already acetaminophen in a prescription drug they are taking at the same time.

Withdrawal of approval coming, could take time

The FDA will now begin withdrawing approval of prescription drugs that contain more than 325 mg. of acetaminophen. However, that process will undoubtedly take time, and during the interim, many patients may still be left unaware of the risks associated with these medications. In the meantime, the FDA is urging patients to carefully read the labels of their prescription medications, to determine whether they contain acetaminophen.

This is not the first FDA Tylenol warning to be published recently. In August, 2013, the agency also warned of rare but serious conditions that can be a side effect of the medication. At that time, a new warning label was placed on Extra Strength Tylenol bottles, stating, “Contains acetaminophen. Always read the label.”

Find a NY medical malpractice attorney

While the FDA is now taking action to protect consumers, there are many over the years who may have suffered the debilitating side effects of an acetaminophen overdose. Some of these individuals may have grounds for legal action against a doctor or hospital if they were not warned about the risks when they were prescribed the drug. In some cases, a medical professional may have prescribed Vicodin and Percocet, but failed to warn the patient that Tylenol was contraindicated with these drugs. In these situations, physicians and healthcare facilities may be held liable for their negligence under New York’s medical malpractice laws.

If you or a family member has suffered from an overdose of acetaminophen, there is help available. You may be eligible to pursue damages to compensate you for injuries, lost wages and past and future medical expenses. To learn more about your legal rights, contact the New York medical malpractice attorneys at The Sanders Firm. Our experienced team is ready to answer your questions and schedule you for a complimentary evaluation of your case. Call us toll-free at 1.800.FAIR.PLAY today.


  1. CNN, FDA: Acetaminophen Doses over 325 mg. might Lead to Liver Damage, http://www.cnn.com/2014/01/15/health/fda-acetaminophen-dosage/

  2. USA Today, FDA Warns against High-Dose Prescription Acetaminophen, http://www.usatoday.com/story/news/nation/2014/01/15/fda-acetaminophen-warning/4489193/

  3. FDA, Acetaminophen Toxicity, http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/ucm230396.htm

  4. FDA Warns of Rare Acetaminophen Risk, http://www.fda.gov/forconsumers/consumerupdates/ucm363010.htm

  5. Fox News, FDA Issues Warning on Drugs Containing Acetaminophen, http://www.foxnews.com/health/2014/01/15/fda-issues-warning-on-drugs-containing-acetaminophen/