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

  • Label RSS
  • 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 03/14

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

  • Active ingredients (in each 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

    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough accompanied by too much phlegm (mucus)

    When using this product,

    do not use more than directed.

    Stop use and ask a doctor if

    cough lasts for 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 right away. (1-800-222-1222)

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  • Directions

    • do not exceed 6 doses in 24 hours
    • take with a full glass of water
    • adults and children 12 years of age and older
      • take 1 tablet every 4 hours
    • children under 12 years of age: do not use
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  • Other information

    • each tablet contains: sodium 20 mg low sodium 
    • store at 20-25°C (68-77°F)
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  • Inactive ingredients

    colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

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  • Principal Display Panel

    Mucus Relief DM

    Dextromethorphan HBr 20 mg

    Guaifenesin 400 mg

    Cough Suppressant • Expectorant

    • Controls cough
    • Thins and loosens mucus

    TABLETS

    DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

    Comments or Questions? 800-632-6900 www.kroger.com

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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  • Product Label

    Dextromethorphan HBr 20 mg, Guaifenesin 400 mg

    Kroger Mucus Relief DM Tablet

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  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM 
    dextromethorphan hydrobromide and guaifenesin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:30142-109
    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
    SILICON DIOXIDE  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONES  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STEARIC ACID  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape OVAL Size 15mm
    Flavor Imprint Code TCL280;G2;G2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-109-30 1 in 1 BOX
    1 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 01/02/2010
    Labeler - The Kroger Co. (006999528)
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