Children under 2 years of age should not be given any kind of cough and cold product that contains a decongestant or antihistamine because serious and possibly life-threatening side effects could occur. Reported side effects of these products included convulsions, rapid heart rates and death. What about older children? When giving cough and cold medicine to children over 2 years of age, parents and caregivers should use caution.
A meeting about the safety and effectiveness of cough and cold drug product use in children by the U.S. Food and Drug Administration in 2007 revealed that there were many reports of harm,
and even death, in children who used these products. During 2004-2005, an estimated 1,519 children less than 2 years of age were treated in U.S. emergency departments for adverse events,
including overdoses, associated with cough and cold medications. Manufacturers voluntarily removed over-the-counter (OTC) infant cough and cold products intended for children under 2 years of age due to these safety concerns.
Cough and cold products for children older than 2 years of age were not affected by the voluntary removal and these products are still sold in pharmacies and other retail outlets. Manufactures also voluntarily re-labeled these cough and cold products to state: “do not use in children under 4 years of age.”