MUCUS RELIEF DM COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]

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  • MUCUS RELIEF DM COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]

MUCUS RELIEF DM COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]
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NDC 0904-6816-46, 0904-6816-52
Set ID 6ecabf21-1026-4773-a9bd-c588aaf5f811
Category HUMAN OTC DRUG LABEL
Packager Major Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredients (in each immediate-release tablet)

    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg

  • Purpose

    Cough suppressant
    Expectorant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • temporarily relieves:
      • cough due to minor throat and bronchial irritation associated with the common cold
      • the intensity of coughing
      • the impulse to cough to help you get to 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 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 exceed recommended dosage.

    Stop use and ask a doctor if

    cough persists more than 7 days, tends to recur, or is accompanied by a 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.

  • Directions

    • take with a full glass of water
    • adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
    • children under 12 years: do not use 
  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • Inactive ingredients

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

  • Questions or comments?

    (800) 616-2471

  • Principal Display Panel

    MAJOR®

    NDC 0904-6816-52

    MucusRelief
    DM COUGH

    Dextromethorphan HBr, 20 mg
    Guaifenesin, 400 mg

    Cough Suppressant
    Expectorant

    • Controls Cough
    • Thins and Loosens Mucus

    Immediate Release

    60 Tablets

    Actual Size

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

    Distributed by: MAJOR® PHARMACEUTICALS
    17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA

    Rev. 09/18    M-17   Re-order No. 701016

    Major 44-533

    Major 44-533

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM COUGH 
    dextromethorphan hbr, guaifenesin tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6816
    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
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 44;533
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6816-4630 in 1 BOTTLE; Type 0: Not a Combination Product12/19/201804/03/2021
    2NDC:0904-6816-5260 in 1 BOTTLE; Type 0: Not a Combination Product12/19/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/19/2018
    Labeler - Major Pharmaceuticals (191427277)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(0904-6816)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0904-6816)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(0904-6816)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(0904-6816)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(0904-6816)
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