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The most frequent adverse reactions to this product are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include:

    Dermatologic: Urticaria, drug rash, photosensitivity, pruritus.

    Cardiovascular System: Hypotension, hypertension, cardiac arrhythmias.

    CNS: Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria and dysphoria.

    G.U. System: Urinary frequency, difficult urination.

    G.I. System: Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.

    Respiratory System: Tightness of chest and wheezing, shortness of breath. At higher doses, codeine has most of the disadvantages of morphine including respiratory depression.

    Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.

DRUG ABUSE AND DEPENDENCE

Codeine can produce a drug dependence of the morphine type, and therefore has the potential for being abused. Psychic dependence, physical dependence, physical dependence and tolerance may develop upon repeated administration of this drug and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.

The product is subject to the Federal Controlled Substances Act (Schedule V).