Black Box Warning

Promethazine hydrochloride injection contains propylene glycol and should not be administered to children younger than 2 years of age due to the risk of respiratory depression, seizures, and cardiorespiratory arrest. Fatal cases have occurred. Postmarketing cases of serious breathing problems, including respiratory arrest, and death have been reported with use of promethazine in children younger than 2 years. Promethazine hydrochloride injection should be given via deep intramuscular injection; inadvertent intra-arterial injection can result in severe arteriospasm, gangrene requiring amputation and/or nerve block. Do not administer by subcutaneous route; severe tissue injury may occur. Extravasation also can result in tissue injury. Deep intravenous injection may be used if properly diluted as recommended in the package labeling. Rapid intravenous injection may cause sudden severe hypotension.