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FDA Considers Requiring Tylenol Dosage Instruction for Infants to Avoid Liver Damage

May 22, 2011

Since the 1950s, the FDA has required that dosing instructions for children under the age of two be left off of children's over-the-counter medications.

This was not intended to confuse parents but to encourage them to seek professional advice from a physician when their child took ill. All it really does at this point in time is create a lot of stress for parents. It is too hard these days to get a hold of a physician on the phone or to try to obtain an appointment to see one to get advice for treating a sick infant. What worked 30 years ago is not working today.

As a result, the FDA is meeting next week to consider adding dosing instructions, for children under the age of 2, to Children's Tylenol and other similar over-the-counter formulas. The products they are focusing on contain acetaminophen, the most common pain reliever and fever-reducing ingredient in these medicines. Acetaminophen toxicity is the leading cause of acute liver failure according to researchers from the University of Washington.

The FDA will consult an outside panel to discuss whether dosing instructions should be added to the group of children's liquid products including Children and Infant's Tylenol, Triaminic, Little Fevers and other drugstore brands that have not carried dosing instructions for children under the age of two.

This is all coming about because the majority of acetaminophen overdoses are occurring in children under the age two. According to the American Association of Poison Control Centers, 7500 (2.8%) of the 270,165 emergencies reported to poison centers last year were due to dosing errors with children's acetaminophen products. Most incidents occur because parents give a formula intended for an adult to a child, or they use a spoon instead of the included dosing implement to give the formula. The FDA will most likely consider these issues and make the following new rules mandatory:

  • Including dosage instructions related to weight and age
  • All manufacturers will need to include a universal measuring cup for all children's formulas.

If your child has suffered severe side effects from acetaminophen including impaired kidney function or liver failure, your child may be entitled to compensation for your child’s injuries. Our Atlanta Tylenol injury claims attorneys represent both children and adults who are injured by the harmful side effects of acetaminophen.

Our Atlanta Tylenol injury claims 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 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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