FDA: OTC cough and cold products should not be used in those under two

January 18, 2008

Do not use OTC cough and cold products among infants and children under two years of age

The FDA has issued a Public Health Advisory for parents and caregivers, recommending that over-the-counter cough and cold products should not be used to treat infants and children less than two years of age because serious and potentially life-threatening side effects can occur from such use. OTC cough and cold products include decongestants, expectorants, antihistamines, and antitussives (cough suppressants) for the treatment of colds. There is a wide variety of rare, serious adverse events reported with cough and cold products. They include death, convulsions, rapid heart rates, and decreased levels of consciousness. The announcement does not include the FDA's final recommendation about use of OTC cough and cold medicines in children ages 2 to 11 years. The agency's review of data for two- to 11-year-olds is continuing. The agency plans to issue its recommendations for this age group as soon as the review is complete. This announcement is based on FDA's review of data and discussion at a joint meeting of the Nonprescription Drugs and Pediatric Advisory Committees on Oct. 18 and 19, 2007. For more information, visit