Create a free Manufacturing.net account to continue

FDA Considers New Dose Info For Kids' Pain Relievers

Officials are considering adding dosing instructions for children younger than two years old, a change favored by drug makers and many doctors.

WASHINGTON (AP) -- Federal health officials are considering adding dosing instructions for children younger than two years old to Children's Tylenol and similar products, a change favored by drugmakers and many doctors.

The Food and Drug Administration meets next week to consider changes to children's over-the-counter formulas containing acetaminophen, the most common pain reliever and fever-reducing ingredient. While safe when used as directed, acetaminophen has long been subject to warning labels because of its potential to cause liver damage when overused.

Children's Tylenol and other acetaminophen products have never contained dosing information for children younger than two because of the liver risk and to encourage parents to seek medical attention for sick infants.

In documents posted Friday the FDA said it will ask an outside panel whether that policy should be changed.