Label: GLUTOSE 15- dextrose gel 

  • NDC Code(s): 0574-0069-15, 0574-0069-30, 0574-0069-45
  • Packager: Paddock Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/09

If you are a consumer or patient please visit this version.

  • DIRECTIONS:

    To treat a hypoglycemic reaction before unconsciousness occurs:

    Twist tip off, squeeze entire contents of tube (15 grams of glucose) into mouth and swallow. If no response within 15 minutes, repeat dosage. If no response within 30 minutes, contact a healthcare provider.

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  • WARNING:

    FOR ORAL USE ONLY. Do not administer to any person who is unconscious or unable to swallow. Not recommended for children under 2 years of age. Keep out of reach of children.

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  • CAUTION:

    Sealed tube. Do not use if tube has been opened or punctured.

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  • STORAGE AND HANDLING

    Store at room temperature.

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  • SPL UNCLASSIFIED SECTION

    (02-06)

    Paddock
    Laboratories, Inc.
    Minneapolis, MN 55427


    Ingredients: purified water, dextrose (d-glucose) USP 40%, glycerin, lemon flavoring, and preservatives in an oral gel base.
    Nutrition Facts
    Serving size 1.3 oz (1 tube)
    Servings per container 1
    Calories 60
    Amount/Serving % Daily Value*
    Total Fat 0g 0%
    Sodium 80mg 3%
    Potassium 98mg 3%
    Total Carbohydrates 15g 5%
      Sugars 15g
    Protein 0g
    Not a significant source of other nutrients.
    *Percent Daily Values based on a 2,000 calorie diet.
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  • PRINCIPAL DISPLAY PANEL - TUBE Glutose 15 Lemon

    Lemon Flavor
    Oral Glucose Gel

    glutose 15™
    for treating Low Blood Sugar

    Net Wt. of gel 37.5 grams

    Meets American Diabetes Association's recommended dose of 15g glucose

    Principle Display Panel  - TUBE Glutose 15 Lemon
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  • PRINCIPAL DISPLAY PANEL - CARTON Glutose Lemon 15

    Also Available in Grape Flavor

    Lemon Flavor
    Oral Glucose Gel

    glutose 15™
    for treating Low Blood Sugar

    MEETS AMERICAN DIABETES
    ASSOCIATION'S RECOMMENDED
    DOSE OF 15G GLUCOSE

    NDC: 0574-0069-30

    Principle Display Panel - CARTON Glutose Lemon 15
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  • PRINCIPAL DISPLAY PANEL - TUBE Glutose 45 Lemon

    Lemon Flavor
    Oral Glucose Gel

    glutose 45™
    for treating Low Blood Sugar

    Delivers 3 doses of 15 grams of Glucose (Net Wt. of gel 112.5 grams)

    Dosage measurements meet American Diabetes Association's recommended dose of 15g glucose

    Principle Display Panel  - TUBE Glutose 45 Lemon
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  • PRINCIPAL DISPLAY PANEL - CARTON Glutose Lemon 45

    Lemon Flavor
    Oral Glucose Gel

    glutose 45™
    for treating Low Blood Sugar

    MEETS AMERICAN DIABETES
    ASSOCIATION'S RECOMMENDED
    DOSE OF 15G GLUCOSE

    NDC: 0574-0069-45

    Principle Display Panel - CARTON Glutose Lemon 45
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  • INGREDIENTS AND APPEARANCE
    GLUTOSE  15
    dextrose gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0574-0069
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    dextrose (dextrose) dextrose 15 g  in 37.5 g
    Inactive Ingredients
    Ingredient Name Strength
    Citric acid monohydrate  
    water  
    dextrose  
    glycerin  
    methylparaben  
    potassium sorbate  
    propylparaben  
    carboxymethylcellulose  
    sodium citrate  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor LEMON Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0574-0069-15 37.5 g in 1 TUBE
    2 NDC:0574-0069-30 3 in 1 CARTON
    2 37.5 g in 1 TUBE
    3 NDC:0574-0069-45 1 in 1 CARTON
    3 112.5 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved other 02/01/1996
    Labeler - Paddock Laboratories, Inc. (086116803)
    Establishment
    Name Address ID/FEI Business Operations
    Paddock Laboratories, Inc. 086116803 MANUFACTURE
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