Pediatric cough and cold medicines update labeling
Date Posted: October 8, 2008
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.