TUKOL MAX ACTION COLD SORE THROAT AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [GENOMMA LAB USA INC]

TUKOL MAX ACTION COLD SORE THROAT AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [GENOMMA LAB USA INC]
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NDC 50066-916-18
Set ID e78ea36b-1e58-48c7-b6f3-7c102ecb0bc8
Category Human OTC Drug Label
Packager Genomma Lab USA Inc
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Drug Facts

    Active ingredients (in each 20 mL)

    Acetaminophen 650 mg
    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg
    Phenylephrine HCl 10 mg

  • Purposes

    Pain reliever/fever reducer
    Cough suppressant
    Expectorant
    Nasal decongestant

  • Uses

    • temporarily relieves these common cold and flu symptoms:
      • nasal congestion
      • cough
      • minor aches and pains
      • sore throat
      • headache
    • temporarily reduces fever
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Warnings


    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening, blisters and rash. If skin reaction occurs, stop use and seek medical help right away.


    Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

  • Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

    • if you are 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

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • a breathing problem such as chronic bronchitis
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    •  cough that occurs with too much phlegm (mucus)
    • trouble urinating due to enlarged prostate gland
  • Ask a doctor or pharmacist before use if

    you are taking the blood thinning drug warfarin

  • When using this product

    do not use more than directed

  • Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • pain, nasal congestion or cough gets worse or lasts more than 7 days
    • cough comes back or occurs with fever, rash, or headache that lasts
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur.

    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.

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.



  • Directions

    • Do not take more than directed
    • Do not take more than 6 doses in 24 hours
    • This adult strength product is not intended for use in children under 12 years of age
    • Dose as follows or as directed by a doctor
    • 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 12 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, sodium citrate, sorbitol, sucralose, 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

    ACETAMINOPHEN / Guaifenesin / Phenylephrine HCI / Dextromethorphan HBr

    Tukol®

    MAX ACTION


    COLD, SORE THROAT & COUGH


    • Fever & Headache
    • Clears Nasal 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

    ACETAMINOPHEN / Guaifenesin / Phenylephrine HCI / Dextromethorphan HBr

    Tukol®

    MAX ACTION


    COLD, SORE THROAT & COUGH


    • Fever & Headache
    • Clears Nasal Congestion
    • Thins & Loosens Mucus
    • Controls Cough

    Ages 12+     6 FL OZ (177 ml)

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 9 FL OZ (177 mL Bottle) - Carton

  • INGREDIENTS AND APPEARANCE
    TUKOL MAX ACTION COLD SORE THROAT AND COUGH 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-916
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    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)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorBLUE (Blue to Bluish Green) Score    
    ShapeSize
    FlavorBERRY, PINEAPPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-916-181 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(50066-916)

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