Label: GUAIFENESIN DM- guaifenesin and dextromethorphan hydrobromide tablet

  • NDC Code(s): 43063-801-60, 43063-801-90
  • Packager: PD-Rx Pharmaceuticals, Inc.
  • 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 September 19, 2018

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

  • Active Ingredient Section

    Active ingredients (per tablet) Purpose

    Guaifenesin 400 mg Expectorant

    Dextromethorphan HBr 20 mg Cough suppressant

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  • 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

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  • 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

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  • 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.

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  • 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)
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  • 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
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  • Pregnancy or breast feeding

    If pregnant or breastfeeding ask a health professional befoe use.

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  • Questions?


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

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  • Storage

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

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

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  • Purpose

    Active Ingredient Purpose

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

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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN DM 
    guaifenesin and dextromethorphan hydrobromide tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43063-801
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color white Score no score
    Shape CAPSULE Size 17mm
    Flavor Imprint Code PH;073
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43063-801-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/14/2017 11/30/2027
    2 NDC:43063-801-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/14/2017 11/30/2027
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 11/14/2017 11/30/2027
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    Name Address ID/FEI Business Operations
    PD-Rx Pharmaceuticals, Inc. 156893695 repack(43063-801)
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