Label: GUAIFENESIN AND CODEINE PHOSPHATE- guaifenesin and codeine phosphate solution 

  • Label RSS
  • NDC Code(s): 0121-0775-04, 0121-0775-16, 0121-1775-05, 0121-1775-10
  • Packager: Pharmaceutical Associates, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CV
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/09

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Each 5 mL (1 teaspoonful) contains Guaifenesin, USP 100 mg and Codeine Phosphate, USP 10 mg.

    Inactive Ingredients: Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sorbitol.

    Sodium Content: 5 mg/5 mL

    Under federal law, Guaifenesin and Codeine Phosphate Oral Solution USP is available without a prescription. Certain state laws may differ.

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  • ACTIONS

    This product combines the expectorant, guaifenesin, with the cough suppressant, codeine. Guaifenesin enhances the output of lower respiratory tract fluid. The enhanced flow of less viscid secretions promotes and facilitates the removal of mucus. Codeine is a centrally acting agent which elevates the threshold for cough.

    As a result, dry, unproductive coughs become more productive and less frequent.

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  • INDICATIONS

    Temporarily controls cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

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  • CONTRAINDICATIONS

    Hypersensitivity to any of the ingredients.

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  • WARNINGS

    A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a physician. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician. Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a physician. May cause or aggravate constipation. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

    Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

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  • DRUG INTERACTION PRECAUTION

    Caution should be used when taking this product with sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the products used alone. (See WARNINGS)

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  • DOSAGE and ADMINISTRATION

    Take orally as stated below or use as directed by a physician. Adults and children 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours, not to exceed 12 teaspoonfuls in a 24-hour period; Children 6 to under 12 years: 5 mL (1 teaspoonful) every 4 hours, not to exceed 6 teaspoonfuls in a 24-hour period; Children under 6 years: consult a physician. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a physician could result in serious side effects for a child. Use of codeine-containing preparations is not recommended for children under 2 years of age. Do not exceed recommended dosage.

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  • STORAGE

    Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.

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  • HOW SUPPLIED

    Guaifenesin and Codeine Phosphate Oral Solution USP (red color-cherry flavor) is supplied in the following oral dosage forms: NDC 0121-0775-04 (4 fl oz bottle), NDC 0121-0775-16 (16 fl oz bottle), NDC 0121-1775-05 (unit dose cups of 5 mL, 10 × 10's) and NDC 0121-1775-10 (unit dose cups of 10 mL, 10 × 10's).

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  • SPL UNCLASSIFIED SECTION

    Pharmaceutical
    Associates, Inc.

    Greenville, SC 29605

    R08/06

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  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 0121-0775-16

    Guaifenesin and Codeine
    Phosphate Oral Solution USP
    CV

    100 mg/10 mg per 5 mL

    Expectorant / Cough Suppressant

    Alcohol Free / Sugar Free

    Each teaspoonful (5 mL) contains:
    Guaifenesin, USP 100 mg
    Codeine Phosphate, USP 10 mg

    Dispense in a tight, light-resistant
    container with a child-resistant closure.

    DO NOT ACCEPT IF IMPRINTED SEAL
    AROUND CAP IS BROKEN OR MISSING.

    16 fl oz (473 mL)

    pai
    Pharmaceutical
    Associates, Inc.

    Greenville, SC 29605

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND CODEINE PHOSPHATE 
    guaifenesin and codeine phosphate solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0121-0775
    Route of Administration ORAL DEA Schedule CV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Guaifenesin (Guaifenesin) Guaifenesin 100 mg  in 5 mL
    Codeine Phosphate (Codeine) Codeine Phosphate 10 mg  in 5 mL
    Product Characteristics
    Color RED Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0121-0775-04 118 mL in 1 BOTTLE
    2 NDC:0121-0775-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 10/01/2006
    GUAIFENESIN AND CODEINE PHOSPHATE 
    guaifenesin and codeine phosphate solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0121-1775
    Route of Administration ORAL DEA Schedule CV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Guaifenesin (Guaifenesin) Guaifenesin 100 mg  in 5 mL
    Codeine Phosphate (Codeine) Codeine Phosphate 10 mg  in 5 mL
    Product Characteristics
    Color RED Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0121-1775-05 10 in 1 CASE
    1 10 in 1 TRAY
    1 5 mL in 1 CUP, UNIT-DOSE
    2 NDC:0121-1775-10 10 in 1 CASE
    2 10 in 1 TRAY
    2 10 mL in 1 CUP, UNIT-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 10/01/2006
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    Name Address ID/FEI Business Operations
    Pharmaceutical Associates, Inc. 044940096 MANUFACTURE
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