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The fda approved promethazine in 1951.

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Long-term animal studies have not been performed to assess the carcinogenic potential of promethazinenor are there other animal or human data concerning carcinogenicitymutagenicity or impairment of fertility with this drugPromethazine was nonmutagenic in the Salmonella test system of Ames.

It is not known whether promethazine HClpromethazine hydrochlorideis excreted in human milkBecause many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from promethazine hydrochloride tabletsa decision should be made whether to discontinue nursing or to discontinue the drugtaking into account the importance of the drug to the mother.

The dosage is based on your agemedical conditionand response to treatmentIn childrenthe dosage may also be based on weightDo not increase your dose or take this medication more often than directed.

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