Label: MUCUS RELIEF DM IMMEDIATE RELEASE- dextromethorphan hbr and guaifenesin tablet

  • NDC Code(s): 69168-543-26, 69168-543-60
  • Packager: Allegiant Health
  • 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 December 10, 2018

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

  • Active ingredient (in each tablet)

    Dextromethorphan HBr 20mg
    Guaifenesin 400mg

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  • Purpose

    Cough Suppressant

    Expectorant

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  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways and make coughs more productive
    • temporarily relieves:
    • cough due to minor sore throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing 
    • the impulse to cough to help you sleep
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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 am 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)

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    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 is accompanied by fever, rash, or persistent headache. These could be signs of a serious illness

    If you are pregnant or breast-feeding,

    ask a health professional before use

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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  • Directions

    Adults and children 12 years of age and older: Take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

    Children under 12 years of age: do not use

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  • Other information

    • store at 25ºC (77ºF) excursions between 15º-30ºC (59º-86ºF)
    • keep in a dry place and do not expose to heat
    • do not use if imprinted safety seal under cap is broken or missing
    • You may report side effects to 1-888-952-0500.
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  • Inactive ingredients

    croscarmellose sodium, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, stearic acid

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  • Principal Display Panel

    Mucus Relief DM

    Mucus Relief DM

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  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM IMMEDIATE RELEASE 
    dextromethorphan hbr and guaifenesin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-543
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 16mm
    Flavor Imprint Code AZ345
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69168-543-26 1 in 1 CARTON 12/23/2014
    1 20 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:69168-543-60 1 in 1 CARTON 12/23/2014
    2 60 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 12/23/2014
    Labeler - Allegiant Health (079501930)
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