Label: TUKOL HONEY DAYTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride syrup

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 11, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each 30 mL)Purpose
    Acetaminophen 650 mgPain reliever/Fever reducer
    Dextromethorphan HBr 20 mgCough suppressant
    Phenylephrine HCl 10 mgNasal Decongestant

  • Uses

    Temporarily relieves cold/flu symptoms:

    • minor aches and pain
    • headache
    • sore throat
    • nasal congestion
    • cough due to minor throat and bronchial irritation
    • temporarily reduces fever
  • Warnings

    Liver warning

    The product contains Acetaminophen. Severe liver damage may occur if you take

    • more than 4 doses (30 mL each) 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 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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two 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
    • thyroid disease
    • diabetes
    • high blood pressure
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma or emphysema
    • cough accompanied by excessive phlegm (mucus)

    Ask a doctor or pharmacist before use

    • if you are taking the blood thinning drug warfarin

    When using this product

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • fever gets worse or lasts more than 3 days
    • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
    • redness or swelling is present
    • cough comes back, or occurs with rash or headache that lasts.
    • 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.

    Overdose warning

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

  • Directions

    • do not take mare than directed
    • do not take more than 4 doses in any 24 hours
    • this adult strength product is not inteded for use in children under 12 years of age
    • measyre only with dosing cup provided
    • keep dosing cup with product
    • mL = mililiter
    • TBSP = tablespoon
    • dose as follows
    agedose
    adults and children 12 years of age and over30 mL (2 tablespoons) every 4 hours
    Children under 12 yearsDo not use
    • When using Day Time and Night Time products, carefully read each label to ensure correct dosing.
  • Other information

    • each 30 mL contains sodium: 18 mg
    • store between 15-30oC (59-86oF)
    • do not refrigerate
  • Inactive ingredients

    Citric acid, FD&C Yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

  • 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 77098

  • PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

    Principal Display Panel - 118 ml Bottle Carton

    Day Time

    Tukol®

    HONEY MULTI SYMPTOM

    COLD & FLU

    Acetaminophen / Dextromethorphan HBr
    / Phenylephrine HCl

    Ages
    12+

    NATURAL
    HONEY
    FLAVOR

    Relieves:

    • HEADACHE, SORE THROAT, FEVER
    • MINOR ACHES AND PAINS
    • NASAL CONGESTION AND COUGH

    4 FL OZ (118 ml)

  • INGREDIENTS AND APPEARANCE
    TUKOL HONEY DAYTIME COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-302
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen21.667 mg  in 1 mL
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide0.667 mg  in 1 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride0.333 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)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HONEY (UNII: Y9H1V576FH)  
    Product Characteristics
    ColorYELLOW (Amber to yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-302-041 in 1 CARTON02/09/2020
    1118 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 DrugM01202/09/2020
    Labeler - Genomma Lab USA (832323534)