Withdrawal of Oral Infant Medicines

The Consumer Healthcare Products Association (CHPA) on behalf of the leading makers of over-the-counter cough and cold medicines announced voluntary market withdrawals of oral cough and cold medicines that refer to “infants.” The voluntry withdrawal affects only these “infant” oral medicines, not those intended and labeled for use in children age two and older. The branded cough and cold medicines that are being voluntarily withdrawn are: Dimetapp® Decongestant Plus Cough Infant Drops Dimetapp® Decongestant Infant Drops Little Colds® Decongestant Plus Cough Little Colds® Multi-Symptom Cold Formula PEDIACARE® Infant Drops Decongestant (containing pseudoephedrine) PEDIACARE® Infant Drops Decongestant & Cough (containing pseudoephedrine) PEDIACARE® Infant Dropper Decongestant (containing phenylephrine) PEDIACARE® Infant Dropper Long-Acting Cough PEDIACARE® Infant Dropper Decongestant & Cough (containing phenylephrine) Robitussin® Infant Cough DM Drops Triaminic® Infant & Toddler Thin Strips® Decongestant Triaminic® Infant & Toddler Thin Strips® Decongestant Plus Cough TYLENOL® Concentrated Infants' Drops Plus Cold TYLENOL® 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. More information about the voluntary withdrawal can be found at www.OTCSafety.org.
http://www.chpa-info.org/ChpaPortal/PressRoom/NewsReleases/2007/10_11_07_CCMedic...