Label: TUKOL HONEY NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate syrup

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 11, 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 30 mL)Purpose
    Acetaminophen 650 mgPain reliever/Fever reducer
    Dextromethorphan HBr 30 mgCough suppressant
    Doxylamine Succinate 12.5 mgAntihistamine
  • Uses

    Temporarily relieves these common cold and flu symptoms:

    • sore throat
    • headache
    • minor aches and pain
    • runny nose and sneezing
    • 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) 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
    • for more than 10 days for pain unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor.
    • 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.
    • to make a child sleepy

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use

    • if you are taking sedatives or tranquillizers
    • if you are taking the blood thinning drug warfarin

    When using this product

    • do not use more than directed
    • avoid alcoholic drinks
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness

    Stop use and ask a doctor if

    • 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 headache that lasts. 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 may cause serious health problems. 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 4 doses in any 24 hours
    • this adult strength product is not intended for use in children under 12 years of age
    • measure 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 6 hours
    Children under 12 years of agedo not use

    when using day time and night time prodcuts, 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 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

    Night Time

    Tukol ®
    HONEY MULTISYMPTOM

    COLD & FLU

    Acetaminophen/ Dextromethorphan HBr /
    Doxylamine succinate

    Ages
    12+

    NATURAL

    HONEY
    FLAVOR

    Relieves:

    • HEADACHE, SORE THROAT, FEVER
    • MINOR ACHES AND PAINS
    • SNEEZING, RUNNY NOSE
    • COUGH

    4 FL OZ (118 ml)

  • INGREDIENTS AND APPEARANCE
    TUKOL HONEY NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-303
    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 HYDROBROMIDE1 mg  in 1 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE0.4167 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HONEY (UNII: Y9H1V576FH)  
    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:50066-303-041 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)