Label: TUKOL X-PECTO MIEL MULTI SYMPTOM COLD- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL

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 August 21, 2019

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  • DRUG FACTSActive 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

    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 DOCTOR/PHARMACIST

    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.

    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

  • 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 yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

  • Questions or comments?

    1 877 99 GENOM (43666)

    Monday to Friday from 8 am to 6 pm, Central time.

  • Tukol X-PECTO MIEL Cough & Cold product label

    Tukol®

    X-PECTO MIEL

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

    Dextromethorphan HBr / Guaifenesin / Phenylephrine HCL

    Cough Suppressant / Expectorant / Nasal Decongestant

    Tukol®

    X-PECTO MIEL

    Cough & Cold

    • Quiets Cough
    • Thins & loosens Phlegm
    • Clears Nasal Congestion

    NATURAL HONEY FLAFOR
    Ages / 12+   4 FL OZ (118 ml)

    2000006935

    6  50066 00042  0

    LOT no.

    Exp.

    Distributed by Genomma Lab USA Inc.

    Houston TX, 77027

    BX-035 Rev. 02

    Genomma Lab.®

    Tokul X-PECTO 533-24 Box VER2

    Tokul X-PECTO 533-24 Btl VER2

    rege

  • INGREDIENTS AND APPEARANCE
    TUKOL X-PECTO MIEL   MULTI SYMPTOM COLD
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-533
    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 YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HONEY (UNII: Y9H1V576FH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorHONEY (HONEY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-533-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/15/2013
    Labeler - Genomma Lab USA, Inc. (832323534)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(50066-533)
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