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FDA Limits Amount of Acetaminophen in Drugs and Requires New Warning Labels

March 15, 2011

The FDA recently announced that it was imposing limits on the amount of acetaminophen (the active ingredient in Tylenol) that could be used in prescription combination drugs and requiring labeling changes on such drugs. The new standard announced by the FDA would limit the amount of acetaminophen used in prescription drugs to no more than 325 milligrams per capsule.

The FDA is also requiring manufacturers of combination prescription drugs that contain acetaminophen to provide a warning that acetaminophen can cause severe liver damage.

Many consumers do not realize that acetaminophen is really the generic version of Tylenol. Many people suffer accidental overdoses of acetaminophen when they combine Tylenol or other over-the-counter cold medicines with prescription combination drugs containing acetaminophen. This can lead unsuspecting consumers to take a high dose of acetaminophen greatly increasing the risk of suffering liver injuries or even liver failure.

If you have suffered severe liver damage from Tylenol, over-the-counter medicines containing acetaminophen or prescription medications containing acetaminophen, you may be entitled to compensation for your injuries. At Montlick and Associates, Attorneys at Law, we represent clients throughout Georgia who suffer serious injuries, such as impaired liver function, liver failure or even wrongful death resulting from their use of Tylenol or other drugs containing acetaminophen. We are dedicated to providing exceptional service as part of our goal of being the best personal injury law firm in Georgia.

"FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use," said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research (CDER). "Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death." Kweder also stated, "The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period."

Acetaminophen is a drug that relieves pain and fever and can be found in both prescription and over-the-counter (OTC) drugs. It is combined in many prescription products with other ingredients, such as Tylenol with Codeine, Percocet and Vicodin. Many people who are suffering with a cold or flu-like symptoms may take an over-the-counter cold medicine or pain reliever like Tylenol and not realize that they are exceeding the safe dose of acetaminophen because it is present in both the over-the-counter medication as well as the combination prescription medication. The difficulty in identifying acetaminophen in prescription drugs is complicated by the fact that it is often labeled as APAP in prescription medications.

According to the FDA, drugs that contain acetaminophen like Tylenol are the leading cause of acute liver failure in the U.S. If you or a loved one has suffered severe acetaminophen-related liver injury or liver failure, Montlick and Associates is prepared to work in your best interests and help you obtain the compensation that you deserve. We work hard for our clients because we want the very best results for them as part of our goal to be the best personal injury law firm in Atlanta.

Our experienced Georgia acetaminophen injury lawyers 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 our attorneys 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

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