Promethazine HCl (Phenergan), NOT For Children Below 2 Years Old

Filed in archive Allergy Medications , Product Alerts on May 2, 2006

The FDA issued a safety alert last week, reminding parents and caregivers to seek medical advise on the use of Promethazine HCl (marketed as Phenergan, but also available as a generic product) in children. The alert was issued after reports of severe breathing problems and even deaths when the antihistamine was used in children below two years old. Caution should also be exercise, according to the FDA, when using this medication for older children.

According to FDA, labels on all products --including syrups, suppositories and tablets-- which contain this substance, have been changed to reflect stronger warnings. Drugs.com has more information on Phenergan.