TUKOL FOR DIABETICS (DEXTROMETHORPHAN HBR AND GUAIFENESIN) LIQUID [GENOMMA LAB USA INC]

TUKOL FOR DIABETICS (DEXTROMETHORPHAN HBR AND GUAIFENESIN) LIQUID [GENOMMA LAB USA INC]
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NDC 50066-806-24
Set ID 5b32b1f3-cce6-44e8-baf5-947964942a01
Category Human OTC Drug Label
Packager Genomma Lab USA Inc
Generic Name
Product Class
Product Number
Application Number PART341
  • Active ingredients (in each 10 mL)

    Dextromethorphan HBr, USP 20 mg
    Guaifenesin, USP 200 mg

  • Purposes

    Cough suppressant
    Expectorant

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • 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 if you have

    • 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

    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.

  • Keep out of reach of children.

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

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided
    • keep dosing cup with product
    • mL = milliliter
    • this adult product is not intended for use in children under 12 years of age

    Age
    Dose
    adults and children
    12 years and over
    10 mL
    every 4 hours
    children under 12 years
    do not use

  • Other information

    • each 10 mL contains: sodium 6 mg
    • store at 20-25°C (68-77°F). Do not refrigerate
    • alcohol-free
    • see bottom panel for lot Number and expiration date
  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, flavors, glycerin, hydroxyethyl cellulose, methyl paraben, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate


  • Questions or Comments

    1-877-99 Genom (43666)

  • PACKAGE LABEL-PRINCIPAL DISPLAY  PANEL - 4 FL OZ (118 mL Bottle)

    NEW 

    COUGH SUPPRESSANT / EXPECTORANT

    Dextromethorphan HBr / Guaifenesin


    Tukol®


    FOR DIABETICS

    COUGH & COLD


    0% SUGAR

    NON-DROWSY


    Relieves:

    Cough
    Mucus

    Specially
    Formulated
    for DIABETICS 

    Ages 12+    4 FL OZ  (118 mL)





    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle)


  • INGREDIENTS AND APPEARANCE
    TUKOL FOR DIABETICS 
    dextromethorphan hbr and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-806
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CHERRY (UNII: BUC5I9595W)  
    VANILLA (UNII: Q74T35078H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) (UNII: M825OX60H9)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorYELLOW (A clear colorless to slightly yellow) Score    
    ShapeSize
    FlavorCHERRY, VANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-806-241 in 1 CARTON06/19/201805/01/2022
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/19/201805/01/2022
    Labeler - Genomma Lab USA Inc (832323534)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(50066-806)

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