Label: MUCINEX DM, CVP HEALTH- guaifenesin and dextromethorphan hydrobromide tablet, extended release
MUCINEX DM, TRAVEL BASIX- guaifenesin and dextromethorphan hydrobromide tablet, extended release
MUCINEX DM- guaifenesin and dextromethorphan hydrobromide tablet, extended release

  • NDC Code(s): 66715-6424-1, 66715-6524-1, 66715-9724-1
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 10, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    (in each extended-release bi-layer tablet)     		Purpose
    Dextromethorphan HBr 30 mgCough suppressant
    Guaifenesin 600 mgExpectorant
  • 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 as may occur with the common cold or inhaled irritants
      • the intensity of coughing
      • the impulse to cough to help you get to sleep
  • Warnings

    Do not use

    • for children under 12 years of age
    • 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

    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough accompanied by too much phlegm (mucus)

    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 illness.

    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

    • do not crush, chew, or break tablet
    • take with a full glass of water
    • this product can be administered without regard for timing of meals
    • adults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours
    • children under 12 years of age: do not use
  • Other information

    • store at 20-25°C (68-77°F)
  • Inactive ingredients

    carbomer homopolymer type B; D&C yellow #10 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

  • Questions?

    1-866-MUCINEX (1-866-682-4639)
    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Product manufactured by:
    Reckitt Benckiser, Parsippany, NJ 07054-0224

    Repackaged and distributed with permission of manufacturer by:
    Lil' Drug Store Products, Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402

  • Mucinex ® DM 2ct, Lil' Drug Store ® - PDP/Package

    Mucinex® DM

    600 mg guaifenesin & 30 mg dextromethorphan HBr

    extended-release bi-layer tablets

    EXPECTORANT & COUGH SUPPRESSANT

    12 HOUR

    [caplet image]

    • Controls Cough
    • Thins And Loosens Mucus

    2 EXTENDED-RELEASE BI-LAYER TABLETS

    [Lil' Drug Store® logo]

    PDP/Package

  • Mucinex ® DM 2ct, TRAVEL BASIX - PDP/Package

    Mucinex ® DM

    600 mg guaifenesin & 30 mg dextromethorphan HBr

    extended-release bi-layer tablets

    EXPEXTORANT & COUGH SUPPRESSANT

    12

    HOUR

    [tablet image]

    [check mark] Controls Cough

    [check mark] Thins and Loosens Mucus

    [check mark] Immediate and Extended release

    2

    EXTENDED-RELEASE

    BI-LAYER TABLETS

    [TRAVEL BASIX logo]

    PDP/Package®

  • Mucinex ® DM 2ct CVP ® HEALTH - PDPPackage

    Mucinex ® DM

    600 mg guaifenesin & 30 mg dextromethorphan HBr

    extended-release bi-layer tablets

    EXPEXTORANT & COUGH SUPPRESSANT

    12

    HOUR

    [tablet image]

    [check mark] Controls Cough

    [check mark] Thins and Loosens Mucus

    [check mark] Immediate and Extended release

    2

    EXTENDED-RELEASE

    BI-LAYER TABLETS

    [CVP ® HEALTH logo]

    PDP/Package

  • INGREDIENTS AND APPEARANCE
    MUCINEX DM, CVP HEALTH 
    guaifenesin and dextromethorphan hydrobromide tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6524
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorwhite (Yellow and white) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code Mucinex;600
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6524-11 in 1 CARTON05/06/2022
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02162005/06/2022
    MUCINEX DM, TRAVEL BASIX 
    guaifenesin and dextromethorphan hydrobromide tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6424
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorwhite (Yellow and white) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code Mucinex;600
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6424-11 in 1 CARTON11/29/2022
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02162011/29/2022
    MUCINEX DM 
    guaifenesin and dextromethorphan hydrobromide tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9724
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorwhite (Yellow and white) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code Mucinex;600
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-9724-11 in 1 CARTON05/10/2010
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02162005/10/2010
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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