Label: COUGH BE GONE - dextromethorphan hydrobromide guaifenesin liquid

  • NDC Code(s): 76206-001-01, 76206-001-10
  • Packager: RFX Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 April 4, 2014

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

  • Active ingredient (in 10 ml)

    Dextromethorphan Hydrobromide 20 mg

    Guaifenesin USP 200 mg

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  • Purpose

    Cough suppressant

    Expectorant

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  • Uses

    ■ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold ■ helps loosen phlegm (mucus) and thin bronchial secretions make coughs more productive

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  • Warnings

    Do not use 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

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  • 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

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  • Stop use and ask a doctor if

    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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  • If pregnant or breast-feeding

    ask a health professional before

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  • Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    ■do not take more than 6 doses in any 24-hour period

    ■one dose is one bottle

    ■this adult product is not intended for use in children under 12 years of age

    Age                                                  Dose

    adults and children 12 years           one bottle (10 ml) every 4 hours

                   and over

    children under 12 years                  do not use

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  • Inactive ingredients

    Almond oil, Citrus peel, Ginger, Honey, Loquat leaf extract, Licorice, Menthol, Purified water

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  • Package Label
  • INGREDIENTS AND APPEARANCE
    COUGH BE GONE 
    dextromethorphan hydrobromide guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76206-001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg  in 10 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALMOND OIL (UNII: 66YXD4DKO9)  
    GINGER (UNII: C5529G5JPQ)  
    HONEY (UNII: Y9H1V576FH)  
    ERIOBOTRYA JAPONICA LEAF (UNII: Z02066SV11)  
    LICORICE (UNII: 61ZBX54883)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color brown (light brown ) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76206-001-01 6 in 1 BOX
    1 NDC:76206-001-10 10 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/30/2014
    Labeler - RFX Pharmaceutical Co., Ltd. (530620871)
    Establishment
    Name Address ID/FEI Business Operations
    RFX Pharmaceutical Co., Ltd. 530620871 manufacture(76206-001)
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