Label: TUKOL MAX ACTION SINUS LIQUID- acetaminophen, guaifenesin, and phenylephrine hydrochloride syrup

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 3, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 20 mL)Purposes
    Acetaminophen 650mgPain reliever
    Guaifenesin 400 mgExpectorant
    Phenylephrine HCl 10 mgNasal decongestant
  • Uses

    temporarily relieves:

    • nasal congestion
    • headache
    • minor aches and pains
    • sinus congestion and pressure
    • temporarily promotes nasal and sinus drainage
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • Warnings

    Liver warning

    This product contains acetaminophen.

    Severe liver damage may occur if you take:

    • more than 6 doses in 24 hours, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert

    Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening, blisters, rash.

    If a skin reaction occurs, stop use and seek medical help right away.

    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 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.
    • for children under 12 years of age

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • thyroid disease
    • high blood pressure
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
    • cough that occurs with too much phlegm (mucus)

    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

    • nervousness, dizziness or sleeplessness occur
    • redness or swelling is present
    • symptoms do not get better within 7 days or are accompanied by a fever
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • cough lasts more than 7 days, comes back, or occurs with 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.

    Overdose warning

    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

    • take only as recommended (see Overdose warning)
    • use dosage cup
    • mL = milliliter
    • do not take more than 6 doses in any 24-hour period
    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
    • dosage cup provided
    • store between 15-30°C (59-86°F)
    • do not refrigerate
  • Inactive ingredients

    Anhydrous citric acid, edetate disodium, FD&C yellow no. 6, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

  • Questions?

    Call weekdays from 8 AM to 6 PM EST at 1-877-994-3666

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 177 ml Bottle Carton

    NEW

    Tukol®

    MAX ACTION

    SINUS

    Headache and Congestion

    Acetaminophen / Guaifenesin / Phenylephrine HCl

    For Ages
    12 & Over

    NATURAL
    GINGER FLAVOR

    ♦
    SINUS CONGESTION
    ♦
    HEADACHE
    ♦
    EXPECTORANT

    6 FL OZ (177 ml)

    PRINCIPAL DISPLAY PANEL - 177 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    TUKOL MAX ACTION SINUS LIQUID 
    acetaminophen, guaifenesin, and phenylephrine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-305
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen32.5 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
    ColorYELLOW (Amber to yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-305-061 in 1 CARTON07/30/2021
    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 FINALpart34107/30/2021
    Labeler - Genomma Lab USA (832323534)
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