FDA records indicate that there are no current recalls for this drug.
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Codeine And Chlorpheniramine Maleate Er Recall
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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)]
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Codeine And Chlorpheniramine Maleate Er Manufacturers
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Nexgen Pharma, Inc.
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