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OTC Industry Supports FDA Advisory Committee Recommendations on New Dosing Instructions
Date:5/18/2011

for children 6 months to 2 years of age.  The committees unanimously voted that the new labeling for children 6 months to 2 years of age include the indication for fever reduction. The committees did not support an indication in labeling for children 6 months to 2 years of age for relief of pain; this indication is currently included for children over 2 years of age.

In addition to including fever reduction as an indication for children 6 months to 2 years of age, CHPA strongly urges FDA to include relief of pain as an indication on the OTC label. Pediatricians recommend acetaminophen as a mainstay for the treatment of pain in children under two years, including pain associated with ear infections, sore throat, teething, and minor traumatic conditions. As experts at the FDA meeting discussed today, physicians can continue to recommend these medicines for pain relief in infants.

In addition to the recommendations discussed at the advisory committee, CHPA member companies recently announced voluntary plans to convert all single-ingredient liquid acetaminophen products for children to a single concentration (160 mg / 5 mL), starting in mid-2011, to help make it easier for parents and caregivers to appropriately use these medicines. Products will continue to be clearly labeled as children's and infants' products and will include flow restrictors that will help make it more difficult for children to ingest large amounts of liquid in the event of an accidental unsupervised ingestion. Syringes will be provided with all infants' products (for children age 3 and under) and children's products (2 years old to under 12 years old) will come with dosing cups. The industry is also voluntarily standardizing all dosing devices with consistent and easily visible measurement markings as well as standardizing the unit of measurement 'mL' on dosing charts and devices.  

As we continue these discussions with FDA, CHPA reminds parents and caregivers to al
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SOURCE Consumer Healthcare Products Association
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