Label: TUKOL MAX ACTION SEVERE CONGESTION AND COUGH- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 11, 2024

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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:
    • nasal congestion
    • cough due to minor throat and bronchial irritation
  • Warnings

    Do not use

    • 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
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • Ask a doctor or pharmacist before use if you are

    taking any other oral nasal decongestant or stimulant.

    Do not exceed recommended dosage.

  • 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 hour period
    • this adult stregth product is not intended for use in children under 12 years of age
    • measure only with dosing cup provided
    • keep dosing cup with product
    • mL = mililiter
     agedose 
     adults and children 12 years of age and older20 mL every 4 hours 
    children under 12 years of age do not use 

  • Other information

    • Each 20 mL dose 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?

    1-877-994-3666
    Monday to Friday from 8 AM to 6 PM, Central time

  • Tukol MAX ACTION Severe Congestion & Cough 

    TukolMaxActionSevere

    Tukol® MAX ACTION

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

    DEXTROMETHORPHAN HBr/GUAIFENESIN/PHENYLEPHRINE HCL

    Relieves

    • Cough
    • Nasal Congestion
    • Chest Congestion

    Ages 12+    

    6 FL OZ (177 mL)

    Distributed by:
    Genomma Lab USA, Inc.
    Houston, TX 77098

  • 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 DrugM01212/16/2016
    Labeler - Genomma Lab USA, Inc (832323534)
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