Label: MUCINEX DM- guaifenesin and dextromethorphan hydrobromide tablet, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 22, 2022

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  • Drug Facts

    Active ingredients (in each extended-release bi-layer tablet)
    Dextromethorphan HBr 30 mg
    Guaifenesin 600 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 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 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
    • children under 12 years of age: do not use
  • Other information

    • store at 20-25°C (68-77°F)
    • FOR YOUR PROTECTION: Do not use if blister is torn or broken.
  • 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?

    About the product, call RB Health (US) at 1-866-MUCINEX (1-866-682-4639)
    You may also report side effects to this phone number.

    For questions about the packaging and labeling, call American Health Packaging at 1-800 707-4621

  • SPL UNCLASSIFIED SECTION

    The name MUCINEX ® and associated trademarks trademark items are used with permission by RB Health.

    The drug product contained in this package is from NDC# 63824-056, RB Health (US).

    Distributed by
    American Health Packaging
    2550 John Glenn Avenue, Suite A
    Columbus, OH 43217

    765121
    5500411/0122

  • Package/Label Principal Display Panel – Carton – 600 mg/30 mg

    600 mg/30 mg Mucinex DM Extended-Release Tablets Carton

    NDC 60687- 651-21

    Mucinex ® DM

    600 mg guaifenesin & 30 mg dextromethorphan HBr
    extended-release bi-layer tablets

    EXPECTORANT & COUGH SUPPRESSANT

    12 HOUR

    Unique Bi-Layer Tablet
    Immediate Release Layer
    Extended Release Layer

    30 Extended-Release Tablets (3 x 10)

    Distributed by
    American Health Packaging
    2550 John Glenn Avenue, Suite A
    Columbus, OH 43217

    765121
    5500411/0122

  • Package/Label Display Panel – Blister – 600 mg/30 mg

    600 mg/30 mg Mucinex DM Extended-Release Tablet Blister

    Mucinex ® DM
    EXPECTORANT & COUGH SUPPRESSANT
    (guaifenesin/dextromethorphan HBr)
    ER Tablet 600 mg/30 mg

  • INGREDIENTS AND APPEARANCE
    MUCINEX DM 
    guaifenesin and dextromethorphan hydrobromide tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-651(NDC:63824-056)
    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
    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)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Colorwhite (white) , yellow (yellow) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code Mucinex;600
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60687-651-2130 in 1 CARTON04/14/2022
    1NDC:60687-651-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02162004/14/2022
    Labeler - American Health Packaging (929561009)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Health Packaging929561009repack(60687-651)
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