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Codrix

Codrix Recall

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Side Effects & Adverse Reactions

In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of the patients with head injuries.

Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions.

Codeine is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

CODRIX™ is indicated for the relief of mild to moderately severe pain.

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History

There is currently no drug history available for this drug.

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Other Information

Acetaminophen and codeine is supplied in tablet form for oral administration.

Acetaminophen, 4′-hydroxyacetanalide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Image from Drug Label Content

Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:

Image from Drug Label Content

Each tablet contains:

Acetaminophen 500 mg

Codeine phosphate 15 mg

In addition each tablet contains the following inactive ingredients: Colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid.

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Codrix Manufacturers

  • Andrx Laboratories, Inc.
    Codrix | Andrx Laboratories, Inc.
    No Recall

    Codrix | Andrx Laboratories, Inc.

    Codrix | Andrx Laboratories, Inc.

    Dosage should be adjusted according to severity of pain and response of the patient.

    The usual adult dosage is:

    Single Doses (range) Maximum 24 Hour Dose Codeine Phosphate 15 mg to 60 mg 360 mg Acetaminophen 300 mg to 1000 mg 4000 mg

    The usual dose of codeine phosphate in children is 0.5 mg/kg.

    Doses may be repeated up to every 4 hours.

    The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. This information should be conveyed in the prescription.

    It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.

  • Andrx Laboratories, Inc.
    Codrix | Andrx Laboratories, Inc.
    No Recall

    Codrix | Andrx Laboratories, Inc.

    Codrix | Andrx Laboratories, Inc.

    Dosage should be adjusted according to severity of pain and response of the patient.

    The usual adult dosage is:

    Single Doses (range) Maximum 24 Hour Dose Codeine Phosphate 15 mg to 60 mg 360 mg Acetaminophen 300 mg to 1000 mg 4000 mg

    The usual dose of codeine phosphate in children is 0.5 mg/kg.

    Doses may be repeated up to every 4 hours.

    The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. This information should be conveyed in the prescription.

    It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.

  • Andrx Laboratories, Inc.
    Codrix | Andrx Laboratories, Inc.
    No Recall

    Codrix | Andrx Laboratories, Inc.

    Codrix | Andrx Laboratories, Inc.

    Dosage should be adjusted according to severity of pain and response of the patient.

    The usual adult dosage is:

    Single Doses (range) Maximum 24 Hour Dose Codeine Phosphate 15 mg to 60 mg 360 mg Acetaminophen 300 mg to 1000 mg 4000 mg

    The usual dose of codeine phosphate in children is 0.5 mg/kg.

    Doses may be repeated up to every 4 hours.

    The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. This information should be conveyed in the prescription.

    It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.

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