GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET [YICHANG HUMANWELL PHARMACEUTICAL CO. LTD.]

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET [YICHANG HUMANWELL PHARMACEUTICAL CO. LTD.]
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NDC 62732-9009-1, 62732-9009-2
Set ID 3d233b7c-1f46-5fd7-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Yichang Humanwell Pharmaceutical Co. Ltd.
Generic Name
Product Class
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active ingredient (per tablet) Purpose
    Dextromethorphan Hydrobromide 20mgCough Suppressant
    Guaifenesin 400mgExpectorant

  • 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.

  • 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.

  • 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

  • Other information

    ■ store at USP controlled room remperature

    ■ protect from heat, humidity, and light

  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    label for DM

    9009

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
    guaifenesin and dextromethorphan hydrobromide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62732-9009
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    Colorwhite (White to off white) Score2 pieces
    ShapeCAPSULESize18mm
    FlavorImprint Code L3Z9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62732-9009-1200 in 1 BOTTLE; Type 0: Not a Combination Product03/03/2017
    2NDC:62732-9009-217000 in 1 BAG; Type 0: Not a Combination Product04/21/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/03/2017
    Labeler - Yichang Humanwell Pharmaceutical Co. Ltd. (527225336)

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