MUCUS RELIEF COUGH (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]

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  • MUCUS RELIEF COUGH (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]

MUCUS RELIEF COUGH (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]
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NDC 50844-733-01
Set ID 2e1407da-b62d-43a9-9b49-f8732754749b
Category HUMAN OTC DRUG LABEL
Packager L.N.K. International, Inc.
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 (77ºF); excursions permitted between 15º-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

    NDC 50844-733-01

    Immediate-Release

    Mucus
    Relief
    Cough

    Guaifenesin 400 mg • Expectorant
    Dextromethorphan HBr 20 mg • Cough Suppressant

    Relieves Chest Congestion
    Controls Cough

    QUALITY GUARANTEED

    30 Tablets

    Actual Size

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

    50844    REV0612C53301

    Manufactured by: LNK International, Inc.
    60 Arkay Drive, Hauppauge, NY 11788

    SATISFACTION GUARANTEED BY REFUND OR EXCHANGE
    Walmart 44-533

    Walmart 44-533

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF COUGH 
    dextromethorphan hbr and guaifenesin tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-733
    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 (UNII: 35SW5USQ3G)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (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
    ColorYELLOWScore2 pieces
    ShapeOVALSize16mm
    FlavorImprint Code 44;533
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50844-733-011 in 1 CARTON12/31/200506/26/2022
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/31/200506/26/2022
    Labeler - L.N.K. International, Inc. (038154464)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(50844-733)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(50844-733)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(50844-733)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(50844-733)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(50844-733)
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