Makers of OTC Cough and Cold Medicines Announce Voluntary Withdrawal of Oral Infant...(CARE(R) Infant Dropper Long-Acting Cough...),Health

-- PEDIACARE(R) Infant Dropper Decongestant & Cough (containing

phenylephrine)

-- Robitussin(R) Infant Cough DM Drops

-- Triaminic(R) Infant & Toddler Thin Strips(R) Decongestant

-- Triaminic(R) Infant & Toddler Thin Strips(R) Decongestant Plus Cough

-- TYLENOL(R) Concentrated Infants' Drops Plus Cold

-- TYLENOL(R) Concentrated Infants' Drops Plus Cold & Cough

This voluntary withdrawal does not affect medicines intended for children age two and older. CHPA and its member companies have put forth recommendations to the U.S. Food and Drug Administration (FDA) to strengthen the labels on all oral OTC children's cough and cold medicines from "ask a doctor" before using to "do not use" in children under two years.

CHPA made these recommendations to the FDA in preparation for a joint FDA advisory committee meeting on October 18 and 19. These recommendations, as well as several additional recommendations, including those proposed by FDA review staff, will be explored further at this meeting.

"These medicines are -and always have been- safe at recommended doses," Suydam said. "These voluntary actions are being taken out of an abundance of caution. The vast majority of parents and caregivers safely use these medicines to help relieve their children's symptoms. But as with all medicines, it's important that parents read over-the-counter medicine labels carefully, use these medicines only as directed, and store them safely out of the reach of children."

CHPA will be launching a major, multi-year national campaign to educate parents and healthcare providers about the safe use of over-the-counter medicines in children, partnering with major physician, nurse, and pharmacist organizations.

More information about the voluntary withdrawal can be found at http://www.OTCSafety.org.

CHPA is the 126-year-old-trade
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