MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]

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  • MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]

MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]
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NDC 21130-933-01
Set ID 5b870e50-8de2-402f-9118-e1d944c0106f
Category HUMAN OTC DRUG LABEL
Packager Better Living Brands, LLC
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

    • 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
  • 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 right away.

  • 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
  • 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
  • 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?

    1-800-426-9391

  • Principal Display Panel

    Signature™
    care

    Quality Guaranteed

    NDC 21130-933-01

    Mucus Relief DM
    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg
    Cough Suppressant/Expectorant

    Immediate-release
    tablets

    • Relieves chest congestion
    • Controls cough

    Actual Size

    30 TABLETS

    TAMPER EVIDENT: DO NOT USE IF CARTON IS
    OPENED OR IF BLISTER UNIT IS TORN, BROKEN
    OR SHOWS ANY SIGNS OF TAMPERING

    DISTRIBUTED BY
    BETTER LIVING BRANDS LLC
    P.O. BOX 99, PLEASANTON, CA 94566-0009
    1-888-723-3929
    www.betterlivingbrandsLLC.com
    50844        REV0612E53301

    OUR PROMISE
    QUALITY & SATISFACTION
    100% GUARANTEED
    OR YOUR MONEY BACK.

    Signature Care 44-533

    Signature Care 44-533


     

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM 
    guaifenesin, dextromethorphan hbr tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-933
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 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, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColoryellowScore2 pieces
    ShapeOVALSize16mm
    FlavorImprint Code 44;533
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-933-013 in 1 CARTON12/31/2005
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/31/2005
    Labeler - Better Living Brands, LLC (009137209)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(21130-933)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(21130-933)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(21130-933)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(21130-933)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(21130-933)
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