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U.S. Department of Health and Human Services

Safety

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Promethazine HCl (marketed as Phenergan and generic products)

Audience: Pediatricians, emergency service professionals and patients
[Posted 04/25/2006] 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.

[April 25, 2006 - Drug Information Page - FDA]