Add Infant Tylenol Dosage to Label, FDA Panel Says

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By Admin on May 23, 2011 6:46 AM

A panel convened by the Food and Drug Administration to discuss over the counter medications voted unanimously last week to mandate the placement of infant Tylenol dosage information on the label for the manufacturer's children's products.

The recommendation, which applies to all medications that contain acetaminophen--the active drug in Tylenol--is aimed at reducing the number of acetaminophen-related overdoses in infants, reports the Associated Press.

As of this moment, federal regulations do not mandate that manufacturers list the infant Tylenol dosage on children's formulas, instead only requiring that they list dosing information for children over 2 years of age.

Parents are instead instructed to discuss dosing information with their infant's doctor.

Though this was originally done as a means to urge parents to seek medical attention for an infant who may be suffering from a serious illness, the Associated Press reports that parents often skip that step and guess about correct dosing.

This has made acetaminophen-related overdoses most common amongst children under 2 years old.

Though the panel recommended providing infant dosage information on medication labels, the fact is that the agency does not have to follow the recommendations of its advisory panels. However, there is some indication that they will follow this advice given the overdose problem.

In addition to infant Tylenol dosage labels, the advisory panel also agreed that products should move towards weight-based dosing, a single-dose acetaminophen formula for children, and that there should be a universal standard for the way the drug is administered, reports MedPage Today.

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