Label: MUCUS RELIEF DM- dextromethorphan hydrobromide and guaifenesin tablet, film coated 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/13

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

  • Active ingredients (in each immediate-release tablet)

    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg

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  • Purpose

    Cough suppressant
    Expectorant

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  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

    • helps loosen phlegm (mucus) and thin bronchial secretions to 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.

    Ask a doctor before use if you have

    • cough accompanied by too much phlegm (mucus)

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

    When using this product

    do not use more than directed.

    Stop use and ask a doctor if

    cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs 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 (1-800-222-1222) right away.

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  • Directions

    • take with a full glass of water

    • adults and children 12 years of age and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.

    • children under 12 years: do not use

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  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
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  • Inactive ingredients

    D&C yellow #10 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

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  • Principal Display Panel

    NDC 41250-533-11

    meijer™

    Immediate Release Cough

    Mucus Reliefer DM
    Guaifenesin • Dextromethorphan HBr
    Expectorant • Cough Suppressant

    Controls Cough
    Things and Loosens Mucus

    60 TABLETS

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    50844     0RG061253311

    DIST. BY MEIJER
    DISTRIBUTION, INC.
    2929 WALKER AVE NW,
    GRAND RAPIDS, MI 49544
    www.meijer.com

    Meijer 44-533

    Meijer 44-533

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  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM 
    dextromethorphan hbr and guiafenesin tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41250-533
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 20 mg
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 400 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POVIDONES  
    SILICON DIOXIDE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STEARIC ACID  
    Product Characteristics
    Color YELLOW Score no score
    Shape OVAL Size 17mm
    Flavor Imprint Code 44;533
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41250-533-11 1 in 1 CARTON
    1 60 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 12/31/2005
    Labeler - Meijer (006959555)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(41250-533)
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