TUKOL MAX ACTION SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [GENOMMA LAB USA INC]

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  • TUKOL MAX ACTION SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [GENOMMA LAB USA INC]

TUKOL MAX ACTION SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [GENOMMA LAB USA INC]
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NDC 50066-917-18
Set ID aaf1322a-d6b4-494c-912c-fd1fd708d614
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 Facts

    Active 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 occurring 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, 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

    • 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

    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 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 take more than 6 doses in any 24 hour period
    • 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 dose contains : sodium 14 mg
    • Store at 20-25°C (68-77°F)
    • do not refrigerate
  • Inactive ingredients

    Citric acid, edetate disodium, FD&C Blue#1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum.

  • Questions or comments?

    1 877 99 GENOM (43666)

    Monday to Friday from 8 AM to 6 PM, Central time.


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

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)

    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)


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)Carton

    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)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle) Carton

  • INGREDIENTS AND APPEARANCE
    TUKOL MAX ACTION SEVERE CONGESTION AND COUGH 
    dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-917
    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) PHENYLEPHRINE HYDROCHLORIDE10 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)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorBERRY, PINEAPPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-917-181 in 1 CARTON11/15/201706/22/2022
    1177 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34111/15/201706/22/2022
    Labeler - Genomma Lab USA Inc (832323534)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(50066-917)
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