Label: MUCUS RELIEF DM COUGH- dextromethorphan hbr and guaifenesin tablet, film coated

  • NDC Code(s): 50844-633-11
  • Packager: L.N.K. International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 10, 2024

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

View All Sections
  • 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 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 15º-30ºC (59º-86ºF)
    • 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

    Quality
      +Plus 

    NDC 50844-633-11

    MUCUS RELIEF
    DM COUGH

    Dextromethorphan HBr, 20 mg
    Guaifenesin, 400 mg

    COUGH SUPPRESSANT
    EXPECTORANT

    • Thins and loosens mucus
    • Controls cough

    60 Tablets

    ACTUAL
    SIZE

    50844  REV0118A53311
    Distributed by
    LNK INTERNATIONAL, INC.
    60 Arkay Drive
    Hauppauge, NY 11788
    USA

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

    PARENTS:
    Learn about teen medicine abuse
    www.StopMedicineAbuse.org


    Quality plus 44-533

    Quality plus 44-533

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM COUGH 
    dextromethorphan hbr and guaifenesin tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-633
    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, UNSPECIFIED (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:50844-633-111 in 1 CARTON08/07/2023
    160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/07/2023
    Labeler - L.N.K. International, Inc. (038154464)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(50844-633, 50844-633)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(50844-633) , pack(50844-633)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(50844-633, 50844-633)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(50844-633)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(50844-633)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!