MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA notified healthcare professionals and patients that cases of breathing problems, some causing death, have been reported to the FDA when the drug was used in children less than two years old. Parents and caregivers should also be careful and get a doctor's advice about giving promethazine HCl in any form to children age two and older. The labeling on all products, brand name and generic, has been changed to reflect these strengthened warnings.
 
Read the complete MedWatch 2006 Safety Summary, including links to the Healthcare professional and patient information sheets, at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#promethazine