Manufacturers of over-the-counter (OTC) children’s cough and cold medicines are voluntarily changing their labels to advise parents not to use in children <4 years of age and not to use antihistamines to sedate children. These changes are the result of manufacturers’ consultation with the FDA to address adverse events related to the misuse of these products. The new labels will be introduced during the 2008-2009 cold and flu season.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm094913.htm.