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

TUKOL MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]
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NDC 50066-504-24
Set ID aef2ad43-145d-4abc-bccc-2c5fdd6882f9
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 tsp)
    Dextromethorphan HBr, USP 10 mg
    Guaifenesin, USP 100 mg
    Phenylephrine HCL, USP 5 mg

  • Purposes

    Cough Suppressant
    Expectorant
    Nasal Decongestant

  • 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 right away.

  • 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

    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.

  • Ask a doctor before use Ask a doctor or pharmacist before use

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema




    Ask a doctor or pharmacist before use if you are

    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

    • you get nervous, dizzy or sleepless
    • 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 persistent headache.

    These could be signs of a serious condition.

  • If pregnant or breast-feeding

    ask a health professional before use.

  • Directions

    • Do not take more than 6 doses in any 24 hour period
    • This adult strength product is not intended for use in children under 12 years of age


    Age - adults and children 12 years and over    Dose - 2 teaspoons every 4 hours

    Age - children under 12    Dose - do not use

  • Other information

    • each teaspoon contains: sodium 3 mg
    • store at 20‐25 ° C (68‐77 ° F). Do not refrigerate.
    • dosage cup provided
  • Inactive ingredients

    anhydrous citric acid, FD and C red no. 40, glycerin, menthol, natural and artificial flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

  • Questions or comments?

    1 877 99 GENOM (43666)

  • Product Label Tukol 504 DPL

    Tukol®

    DO NOT USE IF PRINTED SEAL UNDER CAP

    IS TORN OR MISSING

    Dextromethorphan HBr / Guaifenesin / Phenylephrine HCL

    Expectorant/Cough Suppressant/Nasal Decongestant

    Tukol®

    Cough & Congestion

    • Quiets Cough
    • Thins and loosens phlegm
    • Clears Nasal Congestion

    Ages/ 12+    4 FL OZ (118 mL)

    2000005853

    6  50066 00012  6

    LOT No.
    Exp.

    Distributed by
    Genomma Lab USA Inc.

    Houston, TX 77027

    BX-006  Rev. 03

    Genoma Lab.®

    Tukpl 504-24 Box RV3

    Tukpl 504-24 Botl RV3

    rege

  • INGREDIENTS AND APPEARANCE
    TUKOL MULTI SYMPTOM COLD  
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-504
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-504-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/15/2012
    Labeler - Genomma Lab USA, Inc. (832323534)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(50066-504)

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