BOX WARNING
THE COMBINATION OF PROMETHAZINE HYDROCHLORIDE AND
CODEINE PHOSPHATE IS CONTRAINDICATED IN PEDIATRIC
PATIENTS LESS THAN 16 YEARS OF AGE. CONCOMITANT
ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER
RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH
RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN
PEDIATRIC PATIENTS.
POSTMARKETING CASES OF RESPIRATORY DEPRESSION,
INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF
PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS
THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES
OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN
RESPIRATORY DEPRESSION IN THESE PATIENTS.
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