Label: FLUORIDE - sodium fluoride tablet, chewable

  • NDC Code(s): 51862-171-10, 51862-171-12
  • Packager: Libertas Pharma, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 08/12

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  • DESCRIPTION

    Active Ingredient: 0.5 mg of fluoride ion from 1.1 mg of sodium fluoride (NaF).

    Inactive Ingredients: Lactose, Saccharine, Grape Flavor and Magnesium Stearate.

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  • DOSAGE AND ADMINISTRATION:

    Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth.

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  • STORAGE:

    Store at a Controlled Room Temperature 20º-25ºC (68º-77ºF)

    743633

    Manufactured for:
    Libertas Pharma, Inc.
    Lawrenceville, GA 30043
    Iss. 03/11   171-10

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  • Container Label

    NDC 51862-171-10

    Fluoride Chewable Tablets

    0.5 mg

    (From 1.1 mg of Sodium Fluoride)

    Grape Flavor       1000 Tablets       Rx Only

    Libertas
    Pharma Inc.

    Container Label

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  • INGREDIENTS AND APPEARANCE
    FLUORIDE 
    fluoride tablet, chewable
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51862-171
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    GRAPE (UNII: 6X543N684K)  
    LACTOSE (UNII: J2B2A4N98G)  
    SACCHARIN (UNII: FST467XS7D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Color PURPLE Score no score
    Shape ROUND Size 6mm
    Flavor GRAPE Imprint Code 171
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51862-171-10 1000 in 1 BOTTLE
    2 NDC:51862-171-12 120 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 05/21/2011
    Labeler - Libertas Pharma, Inc. (962128943)
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