Label: GUAIFENESIN DAC- guaifenesin, codeine phosphate and pseudoephedrine hydrochloride liquid  

  • Label RSS
  • NDC Code(s): 16571-301-16
  • Packager: Pack Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CV
  • Marketing Status: unapproved drug other

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 10/09

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

  • INACTIVE INGREDIENTS

    Alcohol 1.9%, artificial cherry flavor, caramel, citric acid, disodium edetate, FD&C Red #40, glycerin, menthol, purified water, saccharin sodium, sodium benzoate, sorbitol solution.

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  • INDICATIONS

    Temporarily relieves cough and nasal congestion as may occur with a cold. 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 4 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.

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  • WARNINGS

    Do not exceed recommended dosage.

    Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by 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. 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. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by fever, consult 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

    Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains a MAOI, consult a health professional before taking this product.

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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.

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  • TAMPER-EVIDENT

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

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  • SPL UNCLASSIFIED SECTION

    BULK CONTAINER - NOT FOR HOUSEHOLD USE.

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  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle

    NDC 16571-301-16
    TAMPER-EVIDENT
    DO NOT REFRIGERATE

    GUAIFENESIN DAC
    ORAL SOLUTION
    CV

    EXPECTORANT
    NASAL DECONGESTANT
    COUGH SUPPRESSANT

    Each teaspoon (5 mL) Contains:
    Guaifenesin USP                                100 mg
    Pseudoephedrine Hydrochloride USP  30 mg
    Codeine Phosphate USP                      10 mg
    contains 1.9% alcohol v/v

    *Under Federal law Guaifenesin DAC
    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 DAC 
    guaifenesin, codeine phosphate and pseudoephedrine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:16571-301
    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
    Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine 30 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    Alcohol  
    Caramel  
    Citric Acid Monohydrate  
    Edetate Disodium  
    FD&C Red no. 40  
    Glycerin  
    Water  
    Saccharin Sodium  
    Sodium Benzoate  
    Sorbitol  
    Menthol  
    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:16571-301-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved other 09/28/2009
    Labeler - Pack Pharmaceuticals LLC (614823875)
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