Charles Ganley, M.D., director of the FDA's Office of Nonprescription Products, said. "These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under 2."  OTC cough and cold products include decongestants, expectorants, antihistamines, and cough suppressants. The Centers of Disease Control and Prevention reported the over the past two years, 1,500 babies and toddlers have wound up in emergency rooms after having bad reactions to cold medicines.  The FDA has not yet completed findings and recommendations for the use of OTC cold remedies for children aged 2 – 11.

However, pending completion of their ongoing review, the FDA has made the following recommendations: Follow the dosing directions on the label of any medication; 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 over-the-counter 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. The FDA has an online Questions and Answers on this issues at their website: www.fda.gov.