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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 carcinogenicitymutagenicityor impairment of fertility with this drugPromethazine was nonmutagenic in the Salmonella test system of Ames.

Before using this medicationtell your doctor or pharmacist your medical historyespecially ofbreathing problemssuch as asthmachronic obstructive pulmonary disease-COPDsleep apneablood/immune system problemssuch as bone marrow depressionhigh pressure in the eyeglaucomaheart diseasesuch as irregular heartbeathigh blood pressureliver diseasecertain brain disorderssuch as neuroleptic malignant syndromeReye’s syndromeseizuresstomach/intestine problemssuch as blockageulceroveractive thyroidhyperthyroidismdifficulty urinatingfor exampledue to enlarged prostate

WARNING/CAUTIONEven though it may be raresome people may have very bad and sometimes deadly side effects when taking a drugTell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

It is unknown if promethazine passes into breast milkIt may have undesirable effects on a nursing infantConsult your doctor before breast-feeding.

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