Label: GUAIFENESIN AC- guaifenesin and codeine phosphate syrup 

  • NDC Code(s): 16571-302-16
  • Packager: Pack Pharmaceuticals LLC
  • 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 09/09

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

  • INACTIVE INGREDIENTS

    Alcohol 3.5%, artificial cherry flavor, caramel, citric acid, disodium edetate, FD&C Red #40, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol solution.

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  • INDICATIONS

    Temporarily relieves 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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  • DIRECTIONS

    Take every 4 hours or as directed by a doctor . Do not exceed 6 doses in 24 hours. Adults and children 12 years of age and over: Take 2 teaspoons. Children 6 to under 12 years of age: Give 1 teaspoon. Children under 6 years of age: Do not use. Giving a higher dose than recommended by a doctor could result in serious side effects for your child. Do not exceed recommended dosage.

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  • WARNINGS

    Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. 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 doctor . 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 doctor. 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.

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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 product used alone.

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  • STORAGE AND HANDLING

    Dispense in a tight, light-resistant container as defined in the USP.

    Store at controlled room temperature 20°-25° C (68 °-77°F). (see USP Controlled Room Temperature) DO NOT REFRIGERATE.

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  • OTHER INFORMATION

    Each 5 mL contains: sodium 4 mg

    TAMPER-EVIDENT: Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing.

    BULK CONTAINER - NOT FOR HOUSEHOLD USE.
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  • QUESTIONS

    TO REPORT ADVERSE DRUG EVENTS CALL: (866) 562-4597

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  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle

    NDC 16571-302-16
    TAMPER-EVIDENT
    DO NOT REFRIGERATE

    Guaifenesin AC CV
    Cough Syrup

    (GUAIFENESIN AND CODEINE
    PHOSPHATE ORAL SOLUTION USP)

    COUGH SUPPRESSANT • EXPECTORANT

    Each teaspoon (5mL) contains:
    Guaifenesin USP                  100 mg
    Codeine Phosphate USP      10 mg
    contains 3.5% alcohol v/v

    *Under Federal law Guaifenesin AC
    is available without a prescription.
    Certain State laws may differ.

    Manufactured by:
    Bio-Pharm, Incorporated Levittown, PA 19057
    Distributed by: PACK PHARMACEUTICALS, LLC
    Buffalo Grove, IL 60089     REV 08/09

    TO REPORT ADVERSE DRUG EVENTS CALL:
    (866) 562-4597

    ONE PINT (473 mL)

    PACK
    PHARMACEUTICALS, LLC

    Principal Display Panel - 473 mL Bottle
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  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN  AC
    guaifenesin and codeine phosphate syrup
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:16571-302
    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 10 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    Alcohol  
    Cherry  
    Caramel  
    Citric Acid Monohydrate  
    Edetate Disodium  
    FD&C Red no. 40  
    Glycerin  
    Water  
    Saccharin Sodium  
    Sodium Benzoate  
    Sorbitol  
    Product Characteristics
    Color BROWN Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16571-302-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/22/2009
    Labeler - Pack Pharmaceuticals LLC (614823875)
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