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CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE ER TABLETS is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older.
Important Limitations of Use
Not indicated for pediatric patients under 18 years of age [see Use in Special Population (8.4)]
CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE ER TABLETS are extended release tablets that contain 54.3 mg of codeine phosphate (equivalent to 40 mg of codeine) and 8 mg of chlorpheniramine maleate (equivalent to 5.6 mg of chlorpheniramine)..
Codeine phosphate [morphine3methyl ether phosphate (1:1) (salt)] hemihydrate, is a narcotic analgesic and antitussive. It has the following structural formula:
Chlorpheniramine maleate is 2-pyridinepropanamine, γ-(4-chlorophenyl)-N,N-dimethyl-, (Z)-2-butenedioate (1:1) and has the following chemical structure:
CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE ER TABLETS are white to off-white, uncoated, standard round extended release matrix tablets.
Other ingredients: hypromellose, lactose monohydrate, cellulose microcrystalline, polysorbate 80, magnesium stearate, and colloidal silicon dioxide.
