Label: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE tablet, extended release

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

Drug Label Information

Updated February 23, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each extended-release 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 (1-800-222-1222).

  • Directions

    • do not crush, chew, or break extended-release 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 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours
    • children under 12 years of age: do not use
  • Other information

    • Store between 20-25°C (68-77°F)
  • Inactive ingredients

    carbomer homopolymer, colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), stearic acid

  • Questions?

    (1-800-406-7984)

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    SAM'S WEST, INC.
    BENTONVILLE, AR 72716

  • PRINCIPAL DISPLAY PANEL - 56 Extended-Release Tablet Blister Pack Carton

    Compare to Maximum Strength Mucinex® DM
    active ingredients*

    NDC 68196-997-56

    Member's Mark™

    Maximum Strength
    Mucus Relief DM

    Guaifenesin 1200 mg &
    Dextromethorphan HBr 60 mg
    Extended-Release Tablets
    Expectorant & Cough Suppressant

    • Controls cough
    • Thins and loosens mucus
    • Immediate and Extended Release

    12
    HOUR

    56
    Extended-
    Release
    Tablets

    PRINCIPAL DISPLAY PANEL - 56 Extended-Release Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
    guaifenesin and dextromethorphan hydrobromide tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-997
    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
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITE (off-white) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 053
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68196-997-561 in 1 CARTON02/16/2022
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21478102/16/2022
    Labeler - SAM'S WEST INC (051957769)
    Registrant - SUN PHARMACEUTICAL INDUSTRIES, INC. (146974886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Pharmaceutical Industries Limited650456002MANUFACTURE(68196-997)
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