Label: TUKOL A- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

  • 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 December 28, 2017

If you are a consumer or patient please visit this version.

  • Active ingredients

    DRUG FACTS


    Active ingredients
    (in each 5 mL, 1 teaspoon)
    Dextromethorphan HBr, USP 5 mg
    Guaifenesin, USP 50 mg
    Phenylephrine HCL, USP 2.5 mg

  • Purpose

    Cough Suppressant
    Expectorant
    Nasal Decongestant

  • Uses

    • help 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
    • diabetes
    • high blood pressure
    • thyroid disease
    • cough that lasts or is chronic such as occurs with asthma
    • 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.

  • When using this product

    • do not use more than directed
  • Stop use and ask a doctor if

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

  • Keep out of reach of children

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • Directions

    age                                               dose

    children 6 to 12 years                    2 tsp (10 mL) every 4 hours

    children 4 to 6 years                     1 tsp (5 mL) every 4 hours

    children under 4 years                  do not use

    • do not exceed 6 doses in a 24-hour period
    • use enclosed dosage cup
    • tsp = teaspoon, mL = milliliter
  • Other information

    • each 5 mL contains: sodium 3 mg
    • store at room temperature
  • Inactive ingredients

    citric acid, FD and C Blue # 1, FD and C Red # 40, flavor, glycerin, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

  • Questions or comments?

    1 877 99 GENOM (43666)

  • Children's Tukol Bottle Label

    Children’s Tukol®

    Cough Suppressant/Expectorant/Nasal Decongestant
    Dextromethorphan HBr | Guaifenesin | Phenylephrine HCI

    Ages 4+

    Cough and Cold

    Gets rid of phlegm
    Quiets Cough
    Clears nasal congestion

    Grape Flavor

    4 FL OZ (118 ml)

    Drug Facts

    Active ingredients                                            Purpose
    (in each 5 mL, 1 teaspoon)
    Dextromethorphan HBr, 5 mg ...............Cough suppressant
    Guaifenesin, 50 mg. .......................................Expectorant
    Phenylephrine HCI, 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 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
    • diabetes
    • high blood pressure
    • thyroid disease
    • cough that lasts or is chronic such as occurs with asthma
    • 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.

    When using this product
    • do not use more than directed

    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 last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

    Drug Facts (continued)

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

    Directions
    • do not exceed 6 doses in a 24-hour period
    • use enclosed dosage cup
    • tsp = teaspoon, mL = milliliter

            age                                       dose
    children 6 to 12 years             2 teaspoons (10 mL) every 4 hours
    children 4 to 6 years               1 teaspoons (5 mL) every 4 hours
    children under 4 years             do not use

    Other information
    • each 5 mL contains: sodium 3 mg
    • store at room temperature

    Inactive ingredients citric acid, FD&C Blue # 1, FD&C Red # 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

    Questions or comments? 1-877-99 GENOM (43666)

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

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    LR-063 Rev. 2

    PEEL HERE

    Tukol-BTL-037-RV2

  • Children's Tukol Box Label

    Children’s Tukol®


    Cough Suppressant/Expectorant/Nasal Decongestant
    Dextromethorphan HBr | Guaifenesin | Phenylephrine HCI

    DO NOT USE IF PRINTED SEAL UNDER CAP
                 IS TORN OR MISSING

    Children’s Tukol®
    Cough Suppressant/Expectorant/Nasal Decongestant
    Dextromethorphan HBr | Guaifenesin | Phenylephrine HCI


    Ages 4+

    Cough and Cold

    Gets rid of phlegm
    Quiets Cough
    Clears nasal congestion

    Grape Flavor

    4 FL OZ (118 ml)

    LOT No.
    Exp.

    Drug Facts

    Active ingredients                                               Purpose
    (in each 5 mL, 1 teaspoon)
    Dextromethorphan HBr, 5 mg ...............Cough suppressant
    Guaifenesin, 50 mg. .......................................Expectorant
    Phenylephrine HCI, 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 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
    • diabetes
    • high blood pressure
    • thyroid disease
    • cough that lasts or is chronic such as occurs with asthma
    • 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.

    When using this product
    • do not use more than directed

    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 last more than 7 days, comes back, or is accompanied by fever, rash or persistent 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) immediately.

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

         3
    66975-3
        8/17

    Drug Facts (continued)

    Directions
    • do not exceed 6 doses in a 24-hour period
    • use enclosed dosage cup
    • tsp = teaspoon, mL = milliliter

         age                                        dose
    children 6 to 12 years         2 teaspoons (10 mL) every 4 hours
    children 4 to 6 years           1 teaspoons (5 mL) every 4 hours
    children under 4 years         do not use

    Other information
    • each 5 mL contains: sodium 3 mg
    • store at room temperature

    Inactive ingredients citric acid, FD&C Blue # 1, FD&C Red # 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

    Questions or comments? 1-877-99 GENOM (43666)

    BX-037 Rev. 02
    2FTAP1MUEWW1B

    Tukol-BX-037-RV2

  • INGREDIENTS AND APPEARANCE
    TUKOL A 
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-536
    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)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (GRAPE FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-536-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/09/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/09/2014
    Labeler - Genomma Lab USA, Inc. (832323534)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(50066-536)