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U.S. Department of Health and Human Services

Safety

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Phenergan (promethazine hydrochloride)

Audience: Pediatricians and other healthcare professionals

FDA and Wyeth notified healthcare professionals of revisions to the CONTRAINDICATIONS, WARNINGS/Use in Pediatric Patients, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Phenergan. Phenergan is contraindicated for use in pediatric patients less than two years of age because of the potential for fatal respiratory depression. Postmarketing cases of respiratory depression including fatalities, have been reported with use of Phenergan in pediatric patients less than two years of age. Caution should also be exercised when administering Phenergan to pediatric patients two years of age and older.

[January 21, 2005 - Letter - Wyeth]
[December, 2004 - Revised Label - Wyeth]