TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.]

TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.]
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NDC 50066-536-24
Set ID 651f0d7c-c76b-434d-95fd-427609b40b46
Category HUMAN OTC DRUG LABEL
Packager Genomma Lab USA, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • 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)

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