Label: MUCOSA DM- dextromethorphan hydrobromide, guaifenesin tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 27, 2023

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  • MHL NDC 54257-277-01 immediate Acting

    Mucosa DM

    EXPECTORANT/COUGH SUPPRESSANT

    Guaifenesin 400 mg

    Dextromethorphan HBr 20 mg

    50 TABLETS

    • Soothes Cough
    • Loosens Congestion
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGE

  • Active ingredients (in each tablet)

    Dextromethorphan HBr 20mg

    Guaifenesin 400 mg

  • Purpose

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

  • Uses

    helps loosen phlegm (mucus), helps thin bronchial secretions to make coughs more productive, temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold.

  • Warnings

    ​a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains MAOI, ask a doctor or pharmacist before taking this product. ​Do not use for children under 12. Do not use if you are now taking

    ​cougha ccompanied with excessive phlegm (mucus), persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema. ​Ask a doctor before use if you have 

    ​ do not use for more than 7 days. ​When using this product do not exceed recommended dosage

    ​ cough lasts for more than 7 days, recurs, or is accompanied with fever, rash, or persistent headache. These could be signs of a serious condition. ​Stop use and ask a doctor if

    ​ask a health professional before use. ​If pregnant or breast-feeding,

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 12 years & older - take one 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 controlled room temperature 15° to 30°C (59° to 86°F) Keep in a dry place and do not expose to excessive heat.
  • Inactive ingredients

    Croscarmellose sodium, maltodextrin, microcrystalline cellulose, povidone, silicon dioxxide, stearic acid.

  • Questions?

    call toll-free 1-800-935-6737

  • ​Distributed by: Magno-Humphries, Inc., OR 97223 U.S.A. Visit our website: ​www.magno-humphries.com

    ​Tigard, OR 97223 U.S.A. ​Distributed by: Magno-Humphries, Inc.

    Visit our website:

    ​www.magno-humphries.com

  • Package Labeling:

    Label

    Drug Facts

  • INGREDIENTS AND APPEARANCE
    MUCOSA DM 
    dextromethorphan hydrobromide, guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54257-277
    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, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code AZ345
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54257-277-0150 in 1 BOTTLE; Type 0: Not a Combination Product04/04/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/04/2017
    Labeler - Magno-Humphries, Inc. (063251433)
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