Label: TUKOL MAX ACTION COLD, FLU AND SORE THROAT- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 14, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 20 mL)Purposes
    Acetaminophen 650mgPain reliever/fever reducer
    Dextromethorphan HBr 20 mgCough suppressant
    Guaifenesin 400 mgExpectorant
    Phenylephrine HCl 10 mgNasal 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 doses (20 mL each) in 24 hours, which is the maximum daily amount for this product.
    • 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 vominting, 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 occuurs 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 even if you do not notice any signs or symptoms.

  • Directions

    • do not take more than directed
    • Do not take more than 4 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
    agedose
    adults and children 12 years and older20 mL every 4 hours
    children under 12 years of agedo not use
  • Other information

    • each 20 mL contains: sodium 10 mg
    • store between 15-30°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.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 177 mL Bottle Carton

    Tukol®
    MAX ACTION

    COLD, FLU AND SORE THROAT

    Acetaminophen / Dextromethorphan HBr/
    Guaifenesin / Phenylephrine HCl

    Ages
    12+

    MAX
    STRENGTH

    Relieves:

    • MINOR ACHES & PAIN
    • FEVER
    • NASAL & CHEST CONGESTION
    • COUGH

    6 FL OZ (177 mL)

    PRINCIPAL DISPLAY PANEL - 177 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    TUKOL MAX ACTION COLD, FLU AND SORE THROAT 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-313
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen32.5 mg  in 1 mL
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide1 mg  in 1 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin20 mg  in 1 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sorbitol (UNII: 506T60A25R)  
    Sodium benzoate (UNII: OJ245FE5EU)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorMENTHOL (Characteristic medicinal) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-313-061 in 1 CARTON06/21/2024
    1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01206/21/2024
    Labeler - Genomma Lab USA (832323534)