MUCUS RELIEF DM IMMEDIATE RELEASE (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET [ALLEGIANT HEALTH]

MUCUS RELIEF DM IMMEDIATE RELEASE (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET [ALLEGIANT HEALTH]
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NDC 69168-543-26, 69168-543-60
Set ID 99fc1c8b-5dd9-4c24-b866-7f776dfb2d84
Category HUMAN OTC DRUG LABEL
Packager Allegiant Health
Generic Name
Product Class
Product Number
Application Number PART341
  • Active ingredient (in each tablet)

    Dextromethorphan HBr 20mg
    Guaifenesin 400mg

  • Purpose

    Cough Suppressant

    Expectorant

  • 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
  • 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.

  • 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

  • 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.
  • Inactive ingredients

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

  • Principal Display Panel

    Mucus Relief DM

    Mucus Relief DM

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM IMMEDIATE RELEASE 
    dextromethorphan hbr and guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-543
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code AZ345
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-543-261 in 1 CARTON12/23/2014
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69168-543-601 in 1 CARTON12/23/2014
    260 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/23/2014
    Labeler - Allegiant Health (079501930)

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