Children’s OTC Cough Syrup Recall

Staff Writer, Oct 16, 2007

The Consumer Healthcare Products Association (CHPA) issued a call for a voluntary withdrawal of over-the-counter (OTC) infant cough and cold elixirs from store shelves. The recall is not mandatory and was initiated by the manufacturers of the OTC children’s cough and cold medicines on October 11. The recall was issued out of caution on the part of manufacturers rather than for safety issues and the CHPA insists that the medicines are safe and effective when taken as prescribed for children over two years of age and it only applies to oral cough and cold medicines.


Government regulators and many pediatricians maintain that cough and cold elixirs do not work as intended for infants or children under the age of two. In fact they contend that their ineffectiveness is what creates the problem to begin with. Because they do not appear to remedy the symptoms, parents are more prone to overdose thinking that more is better and that is where the danger comes into play. According to the U.S. Food and Drug

Administration (FDA), in recent years as many as 54 children have died from OTC decongestants and 69 children have died from OTC antihistamines. It’s unfathomable that a runny nose can lead to your child’s death, but that is exactly what has happened in the majority of the cases involving oral cold medicine overdoses in the last forty years.


The manufacturers of these medicines indicate, on the package, that you should consult your child’s physician for appropriate dosage before administering any medication. However, the American Academy of Pediatrics and many prominent pediatricians feel that children under two should not be given oral decongestions or antihistamines because they have little to no affect and present more of a danger from overdose than help with symptom alleviation. Safety experts for the FDA have advocated for a ban on these medicines for children less than 6 years of age. The FDA plans to meet with outside advisors on October 18 and 19 to discuss the possibility of changing the warnings or instructions for use on these medications.


The recalled medicines include concentrated cough and decongestant cold medicines sold under such well known brands as Dimetapp, Little Colds, Tylenol, PediaCare, Triaminic and Robitussin.  


For a complete list of the cough syrups recalled visit:

www.OTCsafety.org.