PUBLISHED: 4:02 PM on Wednesday, January 23, 2008
Don't give infants or toddlers cold or cough medicines
If your child is less than two years old and has a cold, don't give him or her over-the-counter cold or cough medicines.

So says the U.S. Food and Drug Administration, which has issued a Public Health Advisory for parents and caregivers, recommending that such cough and cold products not be used to treat infants and toddlers because serious and potentially life-threatening side effects can occur from such use.

These cough and cold products include decongestants, expectorants, antihistamines, and antitussives (cough suppressants) for the treatment of colds.

There are a wide variety of rare, serious adverse events reported with cough and cold products, including death, convulsions, rapid heart rates, and decreased levels of consciousness.

"The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than two," said Charles Ganley, M.D., director of the FDA's Office of Nonprescription Products. "These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under two."

The agency plans to issue its recommendations on use of the products in children ages two to 11 years as soon as its review is complete.

Pending completion of the FDA's ongoing review, parents and caregivers that choose to use OTC cough and cold medicines to children ages two to 11 years should:

* Follow the dosing directions on the label of any OTC medication and understand that these drugs will not cure or shorten the duration of the common cold,

* Check the "Drug Facts" label to learn what active ingredients are in the products because many OTC cough and cold products contain multiple active ingredients, and only use measuring spoons or cups that come with the medicine or those made specially for measuring drugs.

The FDA recommends that anyone with questions contact a physician, pharmacist or other health care professional to discuss how to treat a child with a cough or cold.

For more information and the full list of the FDA's recommendations, visit