Label: FLUORIDE - fluoride tablet, chewable

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 26, 2017

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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
    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, UNSPECIFIED FORM (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; Type 0: Not a Combination Product 05/21/2011 11/30/2018
    2 NDC:51862-171-12 120 in 1 BOTTLE; Type 0: Not a Combination Product 05/21/2011 03/31/2020
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 05/21/2011 03/31/2020
    Labeler - Mayne Pharma Inc (867220261)
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