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Promethazine HCl tablets may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Excessively large dosages of antihistamines, including promethazine HCl tablets in pediatric patients may cause sudden death see OVERDOSAGE Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine HCl in pediatric patients.

A patient information leaflet is included and summarizes important information about promethazine. The use of alcohol or other central-nervous-system depressants such as sedatives/hypnotics including barbiturates narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers, may enhance impairment see WARNINGS: CNS Depression and PRECAUTIONS: Drug Interactions Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities.

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