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New FDA Limits on Maximum Dose of Acetaminophen (Tylenol)

February 09, 2011

The FDA announced new limits on the permissible dosage of acetaminophen (active ingredient in Tylenol) last month because of the risk of serious liver impairment, which in extreme cases can result in the need for a liver transplant, liver failure or even death. The new FDA limits direct manufacturers of drugs containing acetaminophen to limit the dosage of acetaminophen to 325 milligrams in prescription medicine.

The FDA also required their most severe "Black Box" warning for all prescription products containing acetaminophen. Some versions of common drugs contain as much as 750 milligrams of acetaminophen. Over-the-counter pain and fever medications that contain acetaminophen, like Tylenol, had already been required to change the dosage labeling to warn consumers regarding the risk of liver damage.

These new measures taken by the FDA are an acknowledgement of the serious liver injuries that can result from use of Tylenol or other drugs that use its active ingredient acetaminophen. At Montlick and Associates, Attorneys at Law, we represent clients who have suffered severe liver damage from Tylenol (acetaminophen). If you or your loved one has suffered serious medical conditions related to your use of acetaminophen including liver or kidney damage, Montlick and Associates may be able to help you.  Contact us for your Free Consultation about your rights and to seek just compensation for your injuries.

Under the current allowable dosage, consumers taking the maximum allowable dose of acetaminophen had an increased risk of liver damage after only four days of taking the medication. A recent study published in the Journal of the American Medical Association, reports that up to 44 percent of study participants who took acetaminophen exhibit elevated levels of liver enzyme abnormalities. Elevated liver enzyme abnormalities are a sign of liver damage. Many people exceed the safe dosage for acetaminophen because they do not realize that acetaminophen is an ingredient in other over-the-counter cold and pain relief medicines. Consumers may inadvertently take Extra-Strength Tylenol and a cold medicine containing acetaminophen not realizing that both drugs contain acetaminophen and that taking the drugs in combination may result in a dangerously high dose of acetaminophen resulting in severe liver damage. This problem is compounded because the ingredient is sometimes listed as APAP, which consumers do not realize is acetaminophen.

If you or someone you love has suffered severe liver damage or other serious health related side-effects from your use of Tylenol or other drugs that contain acetaminophen, contact Montlick and Associates, Attorneys at Law, to discuss your rights to compensation. We represent those injured by defective drugs that are not safely marketed, lack adequate warnings of their risks or are defective in their design and manufacturing.

Our Georgia Tylenol injury attorneys are available to assist clients throughout all of Georgia and the Southeast, including but not limited to Albany, Athens, Atlanta, Augusta, Columbus, Gainesville, Macon, Marietta, Rome, Roswell, Savannah, Smyrna, Valdosta, Warner Robins and all smaller cities and rural areas in the state. No matter where you are located we are just a phone call away, and we will even come to you. Call us 24 hours a day/7 days a week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333). You can also visit us online at and use our Free Case Evaluation Form or 24-hour Live Online Chat.

Category: Personal Injury

Please Note:
All information provided by our blogs is general in nature and should not be relied upon as legal advice. Consult a Montlick attorney for details about your unique situation.