FDA urges parents to read infant acetaminophen labels carefully

December 28, 2011

IRVINGTON, NY, DECEMBER 28, 2011 - Acetaminophen is one of the most commonly used pain and fever relievers for infants and children and is safe and effective when used as directed. However, with recent dosing changes to liquid acetaminophen products for infants, the FDA last week issued a press release urging parents to know the concentration and read the label as the new, less concentrated form of the popular pain reliever arrives on store shelves.

Over the past 12 months, several manufacturers of infant's liquid acetaminophen products, such as PediaCare® and Little Remedies®, voluntarily converted to a single concentration of liquid acetaminophen and added additional product enhancements, including age-appropriate dosing devices. While the new 160 mg per 5 mL concentration is now arriving in drugstores, much of the older, more concentrated 80 mg per 1 mL or 80 mg per 0.8 mL versions may still be in people's medicine cabinets as well as on store shelves.

To help explain and illustrate the changes to infants and children's acetaminophen products, Dr. Jim Sears, pediatrician and co-host of The Doctors, teamed up with PediaCare® and Little Remedies® to create a video explaining the new, smart product changes along with a demonstration of the new special dosing mechanisms. Infant products will now contain a special dosing syringe and flow restrictors on the bottles; children's products, for ages 2 to 11 years, will have the bottles with flow restrictors, and continue to contain dosing cups. Both infant and children's formulations will continue to have weight-based instructions on the package, as well.

"There continues to be a 'transition period' during which the existing concentrated infant products and the new standard strength acetaminophen infant PediaCare and Little Fevers products may be on store shelves simultaneously," says Albert Hwang, Vice President, OTC Products for Prestige Brands, Inc. "The new infant formula is less concentrated and the dose is therefore more than in the older infant formulation. And while reading and following package directions is always recommended to obtain accurate dosing instructions, it will be even more important while the two concentrations are available. Parents and caregivers should ask a healthcare professional if they have any questions," he adds.
-end-
The new PediaCare® and Little Remedies® products are available at drugstores, supermarkets and retailers nationwide. To learn more about the new acetaminophen dosing system for PediaCare® or Little Remedies®, visit www.pediacare.com, www.littleremedies.com or www.youtube.com/pediacare

About Prestige Brands Holdings, Inc.

The Company markets and distributes brand name over-the-counter and household cleaning products throughout the U.S., Canada, and certain international markets. Core brands include Chloraseptic® sore throat treatments, Clear Eyes® eye care products, Compound W® wart treatments, The Doctor's® NightGuard® dental protector, The Little Remedies® and PediaCare® lines of pediatric over-the-counter products, Efferdent® denture care products, Luden's® throat drops and Dramamine® motion sickness treatment.

Robin Leedy & Associates, Inc.

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