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

  • NDC Code(s): 63824-072-02, 63824-072-07, 63824-072-18, 63824-072-35, view more
    63824-072-36, 63824-072-46, 63824-072-48, 63824-072-56
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated August 24, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each extended-release bi-layer tablet)Purposes
    Dextromethorphan HBr 60 mgCough suppressant
    Guaifenesin 1200 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 tablet every 12 hours; not more than 2 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 no. 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

    Dist. by: RB Health (US)
    Parsippany, NJ 07054-0224

    Made in England

  • PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton

    NDC 63824-072-35
    MAXIMUM STRENGTH

    Mucinex®DM
    1200 mg guaifenesin & 60 mg dextromethorphan HBr
    extended-release bi-layer tablets

    EXPECTORANT & COUGH SUPPRESSANT

    12
    HOUR ®

    • Controls Cough
    • Thins and Loosens Mucus
    • Immediate and Extended Release

    14
    EXTENDED-RELEASE
    BI-LAYER TABLETS

    Principal Display Panel - 14 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    MUCINEX DM  MAXIMUM STRENGTH
    guaifenesin and dextromethorphan hydrobromide tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-072
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE60 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)  
    Product Characteristics
    Colorwhite (yellow and white) Scoreno score
    ShapeOVALSize22mm
    FlavorImprint Code Mucinex;1200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-072-071 in 1 CARTON06/26/2012
    17 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63824-072-351 in 1 CARTON06/26/2012
    214 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:63824-072-362 in 1 CARTON06/26/2012
    314 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:63824-072-463 in 1 CARTON06/26/2012
    414 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:63824-072-484 in 1 CARTON06/26/201209/01/2025
    512 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:63824-072-182 in 1 CARTON06/26/201206/15/2022
    69 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:63824-072-564 in 1 CARTON07/01/2021
    714 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:63824-072-021 in 1 CARTON08/01/2021
    81 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02162006/26/2012
    Labeler - RB Health (US) LLC (081049410)
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