Label: TUKOL CHILDREN COUGH AND CONGESTION- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 11, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

     Active Ingredient (in each 5 mL or 1 teaspoon) Purpose
     Dextromethorphan HBr, 5 mg Cough Suppressant
     Guaifenesin, 50 mg Expectorant
     Phenylephrine HCl, 2.5 mg Nasal Decongestant                            

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • temporarily relieves these symptoms occurring with a cold:
      • nasal congestion
      • cough due to minor throat and bronchial irritation
  • Warnings

    Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if the child has

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • cough that lasts or is chronic such 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 the child is taking any other oral nasal decongestant or stimulant.

    Do not exceed recommended dosage.

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occurs
    • symptoms do not get better within 7 days or are accompanied by fever
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Do not take more than 6 doses in any 24 hour period
    • measure only with dosing cup provided
    • keep dosing cup with product
    • TSP = teaspoon
    agedose
    children 6 to under 12 years

    2 teaspoons (10 mL) every 4 hours
    children 4 to under 6 years

    1 teaspoon (5 mL) every 4 hours
    children under 4 years

    do not use

  • Other information

    • each teaspoon (5 mL) contains: sodium 3 mg
    • store at 15-30°C (59-86°F). Do not refrigerate.
  • Inactive ingredients

    citric acid, FD&C blue #1, FD&C red #40, flavor, glyverin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

  • Questions or comments?

    1-877-994-3666

  • 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

    Tukol®

    Children's

    COUGH & CONGESTION

    Dextromethorphan HBr / Guaifenesin / Phenylephrine HCl

    Ages
    4+

    Relieves:

    • COUGH
    • NASAL CONGESTION
    • CHEST CONGESTION

    4 FL OZ (118 ml)

  • INGREDIENTS AND APPEARANCE
    TUKOL CHILDREN COUGH AND CONGESTION 
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-308
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) Dextromethorphan Hydrobromide5 mg  in 5 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin50 mg  in 5 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) Phenylephrine Hydrochloride2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-308-041 in 1 CARTON06/01/2022
    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 DrugM01206/01/2022
    Labeler - Genomma Lab USA (832323534)
    Registrant - Genomma Lab USA (832323534)
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