TUKOL MAX ACTION DM MAX (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [GENOMMA LAB USA INC]

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  • TUKOL MAX ACTION DM MAX (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [GENOMMA LAB USA INC]

TUKOL MAX ACTION DM MAX (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [GENOMMA LAB USA INC]
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NDC 50066-004-65
Set ID f4f5005a-50b1-4a29-94b4-1a7013b46ecd
Category Human OTC Drug Label
Packager Genomma Lab USA Inc
Generic Name
Product Class
Product Number
Application Number ANDA206941
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  • Active Ingredients

    (in each extended-release tablet)
    Dextromethorphan Hydrobromide USP 60 mg
    Guaifenesin USP 1200 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 (1-800-222-1222).

  • 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


    • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
    • store between 20 - 25°C (68 - 77°F)
  • Inactive ingredients


    colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)

  • Questions?


    call 1-877-99-GENOM(4366) You may also report side effects to this phone number. 

    Distributed by
    Genomma Lab USA Inc.,
    Houston, TX, 77027


  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Carton Label)

    MAXIMUM STRENGTH
    Guaifenesin 1200 mg and Dextromethorphan HBr  60 mg     Extended-release Tablets

    TUKOL®
    MAX ACTION
    DM MAX
    Expectorant
    Cough Suppressant
    Controls  Cough/
    Thins and Loosens Mucus/
    14 EXTENDED-RELEASE TABLETS/TABLETS DE LIBERACION PROLONGADA
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Carton Label)

  • INGREDIENTS AND APPEARANCE
    TUKOL MAX ACTION DM MAX 
    guaifenesin and dextromethorphan hbr tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-004
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    POVIDONE K25 (UNII: K0KQV10C35)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (white to off-white) Scoreno score
    ShapeOVALSize22mm
    FlavorImprint Code X;63
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-004-652 in 1 CARTON03/17/2017
    17 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20694103/17/2017
    Labeler - Genomma Lab USA Inc (832323534)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(50066-004) , MANUFACTURE(50066-004)
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