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CONTRAINDICATIONS

Codeine is contraindicated in patients with a known hypersensitivity to the drug.

Promethazine is contraindicated in comatose states, and in individuals known to be
hypersensitive or to have had an idiosyncratic reaction to promethazine or to other
phenothiazines.
The combination of promethazine hydrochloride and codeine phosphate is contraindicated
in pediatric patients less than 16 years of age, because the combination may cause fatal
respiratory depression in this age population.

Antihistamines and codeine are both contraindicated for use in the treatment of lower
respiratory tract symptoms, including asthma.

DRUG ABUSE AND DEPENDENCE

Controlled Substance
Promethazine hydrochloride and codeine phosphate syrup is a Schedule V Controlled
Substance.

Abuse
Codeine is known to be subject to abuse; however, the abuse potential of oral codeine
appears to be quite low. Even parenteral codeine does not appear to offer the psychic
effects sought by addicts to the same degree as heroin or morphine. However, codeine must
be administered only under close supervision to patients with a history of drug abuse or
dependence.

Dependence
Psychological dependence, physical dependence, and tolerance are known to occur with
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