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FDA Advisers Urge Infant Doses for Kids' OTC Fever Relievers
Date:5/18/2011

By Jenifer Goodwin
HealthDay Reporter

WEDNESDAY, May 18 (HealthDay News) -- U.S. health advisers recommended Wednesday that dosing instructions should be added to the labels of medicines containing the widely used pain reliever and fever reducer acetaminophen to better protect children under the age of 2.

In a 21-0 vote, the panel of U.S. Food and Drug Administration advisers called for adding dosing information for children 6 months to 2 years old to over-the-counter medicines such as Children's Tylenol and similar products containing acetaminophen, the Associated Press reported.

Currently, the labels of such medications have dosing instructions for children aged 2 and up. For kids under 2, the labels on the liquid medicines simply tell parents to "ask a doctor."

The FDA advisers said the lack of specific dosing recommendations can lead to confusion, with parents unintentionally giving too much of the medicine to children under age 2. Acetaminophen-related overdoses are most common among children younger than 2, and have increased over the past decade, according to FDA data.

Wednesday's vote focused only on a small group of single-ingredient products, including J&J's Children and Infants' Tylenol, Novartis' Triaminic, Prestige Brands' Little Fevers and assorted drugstore brands, the AP said.

In a second vote Wednesday, the panel recommended unanimously that these medicines should also include dosing information based on children's weight -- considered the most accurate way to determine the proper dose. Nearly all over-the-counter manufacturers already include a dosing table with both weight and age. But the FDA advisers said instructions must emphasize that weight is the preferred approach, the AP reported.

In a third vote, the advisers recommended 17-3, with one abstention, that the FDA consider requiring a single dosage for children's solid acetaminophen tablets, th
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