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G Tron (Kramer Novis)

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SYRUP 474 mL in 1 BOTTLE (52083-601-16) Label Information

Complete G Tron Information

  • ACTIVE INGREDIENT

    Active Ingredients (In Each 5ml (tsp))                       
    Guaifenesein    100 mg
    Dextromethorphan HBr. 10 mg


  • INDICATIONS & USAGE

    Uses: helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial
    passages of bothersome mucus, drain bronchial tubes, and make coughs
    more productive
    restores free breathing
    suppresses cough due to minor throat and bronchial irritation associated with a
    cold or inhaled irritants


  • DOSAGE & ADMINISTRATION

    Directions

    do not take more than 6 doses in any 24-hour period
    Adults and Children 12 years of age and over 10 mL (2 tsp)
    Children 6 to under 12 years of age 5 mL (1 tsp) E V E RY
    4 HOURS

    Children 2 to under 6 years of age 2.5 mL (½ tsp)
    Children under 2 year of age Consult physician
  • WARNINGS

    Warnings:
    Do not:
    use more than the recommended dose
    give this product to a child who has heart disease, high blood pressure, thyroid
    disease, or diabetes unless directed by a doctor.
    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.
    diabetes heart disease thyroid disease high blood pressure 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 before use if you have
    When using this product do not use more than directed.


  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding baby, ask a health professional  
    before use.


  • 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.  
    Prompt medical attention is critical for adults as well as for  
    children even if you do not notice any signs or symptoms.


  • INACTIVE INGREDIENT

    Enter section text here


  • PRINCIPAL DISPLAY PANEL

    MMGTRON16ozlabel1


  • PURPOSE

    Purpose: Expectorant, Cough Suppressant


  • INGREDIENTS AND APPEARANCE
    G TRON 
    guaifenesin dextromethorphan syrup
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-601
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CHERRY (UNII: BUC5I9595W)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (sour cherry) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52083-601-16 474 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/18/2012
    Labeler - Kramer Novis (090158395)
    Registrant - Ultraseal Corporation (085752004)
    Establishment
    Name Address ID/FEI Business Operations
    Ultratab Laboratories, Inc. 151051757 manufacture(52083-601)