Label: TUKOL CHILDREN COUGH AND CONGESTION- dextromethorphan hydrobromide, 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 May 16, 2023

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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

    Tukol®

    Children's

    COUGH & CONGESTION

    Dextromethorphan HBr / Guaifenesin / Phenylephrine HCl

    Ages
    4+

    Relieves:

    • COUGH
    • NASAL CONGESTION
    • CHEST CONGESTION

    4 FL OZ (118 ml)

    Principal Display Panel - 118 ml Bottle Carton

  • 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 FINALpart34106/01/2022
    Labeler - Genomma Lab USA (832323534)
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