Label: BIO-Z-COUGH - dextromethorphan hydrobromide and guaifenesin liquid 

  • Label RSS
  • NDC Code(s): 45737-251-16
  • Packager: Advanced Generic Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • 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 10/12

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

  • ACTIVE INGREDIENT

    Active Ingredients (in each 5 mL tps.)                               Purpose

    Dextromethorphan Hydrobromide.... 20 mg...........................Cough suppressant

    Guaifenesin.... 400 mg........................................................Expectorant


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  • PURPOSE


    Uses:

    • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
    • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
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  • WARNINGS

    Warnings:

    Ask a doctor before use if you have:

    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.


    When using this product do not use more than directed.

    Stop use and ask a doctor before use if:

    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.




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  • DO NOT USE


    Do not use:

    If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs of depression, psychiatric, or emotional conditions or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if you are taking a prescription drug that contains MAOI; ask your doctor or pharmacist before taking this product.


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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

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  • DOSAGE & ADMINISTRATION

    Direction: do not exceed more than 6 doses in any 24 hours period.

    Adults and children 12 years of age and over.
     Take 1 teaspoonful (5 mL) every 4 hours
    Children under 12 years of age.
     Consult a physician
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  • INDICATIONS & USAGE


    Other Information:
    • Store at room temperature 15 - 30 degrees celsius (59 - 86 degrees farenheit)
    • Tamper evident feature Do not use if seal under cap is torn, broken or missing.
    • Avoid excessive heat or humidity.



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  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Citric Acid, eucalyptus oil, menthol, methylparaben, propylparaben, propylene glycol, sodium citrate, polyethylene glycol, grape flavor, sucralose, and purified water.


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  • QUESTIONS

     
    Questions or comments? 1-305-403-3788

    Manufactured for: Advanced Generic Corporation
                              Miami, FL 33166

    www.advancedgeneric.com
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  • INGREDIENTS AND APPEARANCE
    BIO-Z-COUGH 
    dextromethorphan hydrobromide, guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:45737-251
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN ) DEXTROMETHORPHAN HYDROBROMIDE 20 mg  in 5 mL
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 400 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    EUCALYPTUS OIL  
    MENTHOL  
    METHYLPARABEN  
    PROPYLPARABEN  
    POLYETHYLENE GLYCOLS  
    SUCRALOSE  
    WATER  
    PROPYLENE GLYCOL  
    SODIUM CITRATE  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE (grape flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45737-251-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/01/2012
    Labeler - Advanced Generic Corporation (831762971)
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