GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]

GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]
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NDC 43063-801-60, 43063-801-90
Set ID ac8c0c15-b305-47f2-8712-e4b53636f7fa
Category HUMAN OTC DRUG LABEL
Packager PD-Rx Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
  • Active Ingredient Section

    Active ingredients (per tablet) Purpose

    Guaifenesin 400 mg Expectorant

    Dextromethorphan HBr 20 mg Cough suppressant

  • Keep Out Of Reach of Children

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately (800)222-1222

  • Indications & Usage

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

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

    Helps make coughs more productive.

    These highlights do not include all the information needed to use Guaifenesin DM, See full prescribing information for Guaifenesin DM Initial U.S. Approval 04/29/2004

  • Warnings

    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.

  • Ask doctor before use.

    Ask a doctor before use if

    • Persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • Cough accompanied by excessive phegm (mucus)
  • Stop Use Section

    Stop use and ask a doctor if

    • Symptons 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 sondition
  • Pregnancy or breast feeding

    If pregnant or breastfeeding ask a health professional befoe use.

  • Questions?


    Questions? Adverse drug event call : (866) 562-2756

  • Storage

    • Other Informtion
    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • Inactive Ingredient

    Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Stearic Acid

  • Purpose

    Active Ingredient Purpose

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

    Dextromethorphan HBr 20mg.............Cough Suppressant

  • DOSAGE & ADMINISTRATION

    Directions: Adults and children 12 years of age and older, take 1 tablet every 4 hours as needed with a full glass of water while symptoms persist.

    Do not exceed 6 doses in 24 hours.

    Children 6 to 12 years of age take 1/2 tablet every 4 hours as needed with a full glass of water.

    Children under 6 years of age consult a doctor.

    These highlights do not include all the information needed to use Guaifenesin DM

    See full prescribing information for Guaifenesin DM

    Initial U.S. Approval 04/29/04

  • PRINCIPAL DISPLAY PANEL

    image

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN DM 
    guaifenesin and dextromethorphan hydrobromide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43063-801
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code PH;073
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43063-801-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/14/201711/30/2027
    2NDC:43063-801-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/14/201711/30/2027
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/14/201711/30/2027
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD-Rx Pharmaceuticals, Inc.156893695repack(43063-801)

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