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

  • NDC Code(s): 70000-0278-1, 70000-0278-2
  • Packager: Cardinal Health 110, LLC. DBA Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 2, 2023

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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 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

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • see end flap for expiration date and lot number
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) 
  • 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

    LEADER™

    NDC 70000-0278-1

    Maximum Strength 
    Mucus Relief
    DM Cough

    Dextromethorphan HBr, 20 mg ι Guaifenesin, 400 mg
    Cough Suppressant ι Expectorant

    Controls Cough
    Thins and Loosens Mucus

    Immediate-Release Tablets

    24 TABLETS

    ACTUAL SIZE

    100% Money Back Guarantee

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

    50844     REV0118A53315

    CIN 5326137 REV. 5/22

    CardinalHealth™
    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OH 43017
    www.myleader.com      1-800-200-6313
    Essential to Care™ since 1979

    © 2022 Cardinal Health. All Rights Reserved.
    CARDINAL HEALTH, the Cardinal Health
    LOGO, LEADER, and the Leader LOGO are
    trademarks or registered trademarks of
    Cardinal Health.

    All LEADER™ Brand Products Have A
    100% Money Back Guarantee
    Return to place of purchase if not satisfied.

    Leader 44-533

    Leader 44-533

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM COUGH  MAXIMUM STRENGTH
    dextromethorphan hbr and guaifenesin tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0278
    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:70000-0278-12 in 1 CARTON12/31/2005
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:70000-0278-21 in 1 CARTON12/31/200512/04/2022
    250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/31/2005
    Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(70000-0278)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(70000-0278) , pack(70000-0278)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(70000-0278)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(70000-0278)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(70000-0278)
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