TUKOL MAX ACTION SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GENOMMA LAB USA, INC]

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  • TUKOL MAX ACTION SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GENOMMA LAB USA, INC]

TUKOL MAX ACTION SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GENOMMA LAB USA, INC]
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NDC 50066-517-25
Set ID 9ac3e24a-d18a-48fc-8005-55393085d57b
Category HUMAN OTC DRUG LABEL
Packager Genomma Lab USA, Inc
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Drug FactsActive ingredients(in each 20 mL)

    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg
    Phenylephrine HCL 10 mg

  • Purpose

    Cough suppressant
    Expectorant
    Nasal decongestant

  • Uses

    • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • temporarily relieves these symptoms occuring with a cold
    • cough due to minor throat and bronchial irritation
    • nasal congestion
  • 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, psychiatic, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping an 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

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • trouble urinating due to enlarged prostate gland
  • When using this product

    When using this product do not use more than directed

  • Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or are accompanied by fever
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache

    These could be signs of a serious condition.

  • If pregnant or breast-feeding

    ask a 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 take more than 6 doses in any 24 hours
    • Use dose cup provided

    Age                                                       Dose
    Adults and children
    12 years and older                                20 mL every 4 hours

    Children under 12 years of age            Do not use

  • Other information

    • Each 20 mL contains: sodium 10 mg
    • store between15-30°C (59-86 °F)
    • do not refrigerate
  • Inactive Ingredients

    Anhydrous citric acid, edetate disodium, FD&C Blue # 1, FD&C Red # 40, flavors, glycerin, propylene glycol, propyl gallate, Purified water, sodium benzoate, Sorbitol, sucralose, xanthan gum

  • Questions or comments?

    1-877-99-Genom (43666)
    Monday to Friday from 8 AM to 6 PM, Central time

  • Tukol MAX ACTION Severe Congestion & Cough product label

    Tukol® MAX ACTION

    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    NEW MAX STRENGTH

    DEXTROMETHORPHAN HBr/GUAIFENESIN/PHENYLEPHRINE HCL

    Tukol® MAX ACTION
    Severe
    CONGESTION & COUGH

    • Clears Nasal & Chest Congestion
    • Thins & Loosens Mucus
    • Controls Cough

    Ages 12+     6 FL OZ (177 mL)

    Distributed by:
    Genomma Lab USA, Inc.
    Houston, TX 77027
    Box number: BX-064

    AptaPharma TukolMaxActionSevere 517

    AptaPharma TukolMaxActionSevere 517-1

  • INGREDIENTS AND APPEARANCE
    TUKOL MAX ACTION SEVERE CONGESTION AND COUGH 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-517
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-517-25177 mL in 1 BOTTLE; Type 0: Not a Combination Product12/16/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/16/2016
    Labeler - Genomma Lab USA, Inc (832323534)
    Registrant - AptaPharma Inc (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc790523323manufacture(50066-517) , relabel(50066-517) , repack(50066-517)
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