Label: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE- guaifenesin and dextromethorphan hydrobromide tablet

  • NDC Code(s): 62732-9009-1, 62732-9009-2
  • Packager: Yichang Humanwell 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 21, 2017

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  • ACTIVE INGREDIENT

    Active ingredient (per tablet) Purpose
    Dextromethorphan Hydrobromide 20mg Cough Suppressant
    Guaifenesin 400mg Expectorant

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  • Uses

    ■Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold

    ■Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus

    ■Helps 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 a MAOI, ask a doctor or pharmacist before using this product.

    Ask a doctor before use if you have

    ■ persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    ■ cough that is accompanied by excessive phlegm (mucus)

    Stop use and ask a doctor if

    ■ symptoms are accompanied by fever, rash, or persistent headache

    ■ cough persists for more than 1 week or tends to recur.

    A persistent cough may be a sign of a serious condition.

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

    Keep out of reach of children.

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

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  • Directions

    Adults and children 12 years and over: take 1 tablet every 4 hours as needed

    Children 6 to under 12 years: take 1/2 tablet every 4 hours as needed

    Children under 6 years: consult a doctor

    Do not exceed 6 doses in a 24 hour period or as directed by a doctor

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  • Other information

    ■ store at USP controlled room remperature

    ■ protect from heat, humidity, and light

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  • INACTIVE INGREDIENT

    Inactive ingredientscolloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate.

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  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
    guaifenesin and dextromethorphan hydrobromide tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62732-9009
    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
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE K29/32 (UNII: 390RMW2PEQ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Color white (White to off white) Score 2 pieces
    Shape CAPSULE Size 18mm
    Flavor Imprint Code L3Z9
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62732-9009-1 200 in 1 BOTTLE; Type 0: Not a Combination Product 03/03/2017
    2 NDC:62732-9009-2 17000 in 1 BAG; Type 0: Not a Combination Product 04/21/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 03/03/2017
    Labeler - Yichang Humanwell Pharmaceutical Co. Ltd. (527225336)
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