- Potential misuse of these infant medicines, not product safety, is
driving the voluntary withdrawal - This withdrawal does not affect cough and cold medicines for children age
2 and older - Further evaluation of these oral cough and cold medicines for infants and children will occur at the October 18 and 19 FDA advisory committee meeting
WASHINGTON, Oct. 11 /PRNewswire/ -- The Consumer Healthcare Products Association (CHPA) on behalf of the leading makers of over-the-counter cough and cold medicines today announced voluntary market withdrawals of oral cough and cold medicines that refer to "infants." The voluntary withdrawal affects only these "infant" oral medicines, not those intended and labeled for use in children age two and older.
"It's important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately," said Linda 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 withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority."
The branded cough and cold medicines that are being voluntarily withdrawn are:
-- 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
-- PEDIACARE(R) Infant Dropper Decongestant (containing phenylephrine)
|SOURCE The Consumer Healthcare Products Association|
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