The U.S. Food and Drug Administration's (FDA) Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee have recommended to enhance the labels of all OTC single-ingredient pediatric acetaminophen products.
The revised labels will include dosing instructions for children between ages 6 months to 2 years of age, based on weight and age. The label will also include dosing instructions by weight as well as age on the drug facts label for all children’s single-ingredient acetaminophen medicines.
The panel said that Tylenol, infant acetaminophen should be labeled only for fever reduction in children under age 2. Labels may recommend acetaminophen for both fever and pain in children over age 2.
The panel also found little evidence to label over-the-counter acetaminophen for pain relief in infants under age 2.
The panel has advised the FDA to recommend acetaminophen makers to change the bottles of liquid acetaminophen to make it harder for kids to take an accidental overdose. The committee also advised that liquid acetaminophen bottles to be made with a measuring device clearly marked in milliliters using the standard "mL" abbreviation.