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 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The branded cough and cold medicines that are being voluntarily withdrawn are: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® 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.
"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 www.OTCSafety.org.