Makers of OTC Cough and Cold Medicines Announce Voluntary Withdrawal of Oral Infant Medicines

Friday, October 12, 2007 General News
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WASHINGTON, Oct. 11 The Consumer Healthcare ProductsAssociation (CHPA) on behalf of the leading makers of over-the-counter coughand cold medicines today announced voluntary market withdrawals of oral coughand cold medicines that refer to "infants." The voluntary withdrawal affectsonly these "infant" oral medicines, not those intended and labeled for use inchildren age two and older.

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"It's important to point out that these medicines are safe and effectivewhen used as directed, and most parents are using them appropriately," saidLinda A. Suydam, D.P.A, president of CHPA. "The reason the makers of over-the-counter, oral cough and cold medicines for infants are voluntarily withdrawingthese medicines is that there have been rare patterns of misuse leading tooverdose recently identified, particularly in infants, and safety is our toppriority."

The branded cough and cold medicines that are being voluntarily withdrawnare:

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

CHPA made these recommendations to the FDA in preparation for a joint FDAadvisory committee meeting on October 18 and 19. These recommendations, aswell as several additional recommendations, including those proposed by FDAreview 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 ofcaution. The vast majority of parents and caregivers safely use thesemedicines to help relieve their children's symptoms. But as with allmedicines, it's important that parents read over-the-counter medicine labelscarefully, use these medicines only as directed, and store them safely out ofthe reach of children."

CHPA will be launching a major, multi-year national campaign to educateparents and healthcare providers about the safe use of over-the-countermedicines in children, partnering with major physician, nurse, and pharmacistorganizations.

More information about the voluntary withdrawal can be found

CHPA is the 126-year-old-trade association representing U.S. manufacturersand distributors of over-the-counter medicines and nutritional supplementproducts.

Contacts: Elizabeth Funderburk and Virginia Cox-- Dimetapp(R) Decongestant Plus Cough Infant Drops -- Dimetapp(R) Decongestant Infant Drops -- Little Colds(R) Decongestant Plus Cough -- Little Colds(R) Multi-Symptom Cold Formula -- PEDIACARE(R) Infant Drops Decongestant (containing pseudoephedrine) -- PEDIACARE(R) Infant Drops Decongestant & Cough (containing pseudoephedrine) -- PEDIACARE(R) Infant Dropper Decongestant (containing phenylephrine) -- PEDIACARE(R) Infant Dropper Long-Acting Cough -- 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

SOURCE The Consumer Healthcare Products Association

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