OTC Infant Cold Medicines Pulled from Store ShelvesChildren

Doctors Say Antihistamines and Decongestants Are Dangerous and Ineffective

Health Notes Archives - Click HereBy Christina Elston

For babies and toddlers with colds, over-the-counter remedies may be a thing of the past. In mid-October, a panel of experts advising the U.S. Food and Drug Administration (FDA) recommended a ban on the sale of over-the-counter cold medications for children younger than 6 years old. While the agency isn’t required to follow the recommendations of its panels, it generally does.

Just prior to the panel recommendations, several leading manufacturers of these medications had voluntarily pulled at least 14 types of infant oral medications from store shelves. The Consumer Healthcare Products Association (CHPA), which represents makers of over-the-counter medicines, reported that the following products were withdrawn:

  • Dimetapp Decongestant Infant Drops

  • Dimetapp Decongestant Plus Cough Infant Drops

  • Little Colds Decongestant Plus Cough

  • Little Colds Multi-Symptom Cold Formula

  • Pediacare Infant Dropper Decongestant

  • Pediacare Infant Dropper Decongestant & Cough

  • Pediacare Infant Dropper Long-Acting Cough

  • Pediacare Infant Drops Decongestant

  • Pediacare Infant Drops Decongestant & Cough

  • 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

An FDA safety review of nearly four decades of data revealed dozens of deaths linked to accidental overdoses of the medications, most of them in children under age 2.

The problematic ingredients in these medications, according to pediatrician Ari Brown, M.D., are decongestants such as pseudophedrine or phenylephrine, antihistamines like carbinoxamine, and cough medications like dextromethorphan. Minor side effects associated with these medications include agitation or insomnia, while more severe side effects include hallucination, elevated blood pressure and heart rhythm abnormalities.

“These latter side effects, in some cases, can and have been fatal when children were accidentally overdosed,” says Brown, a spokesperson for the American Academy of Pediatrics (AAP).

“Here’s the rub,” Brown says, “the products are only marginally helpful in treating the symptoms of a common cold or flu. They do not treat the disease, and parents need to know that.”

“What I have seen,” Brown adds, “is kids who can’t fall asleep after taking them. It’s like having a double espresso from Starbucks! I’d rather have a snotty sleeping baby than a snotty awake one.”

Rather than resorting to a dose of over-the-counter medication for your infant, Brown suggests using saline nose drops and a humidifier to loosen secretions in the nose, and providing lots of T.L.C. to keep your baby comfortable. She also has a reminder for parents: “The best cure for the common cold is time.”


Christina Elston is a senior editor and health writer for Dominion Parenting Media.

Updated January 2008.

More Health Updates