Label: FLUORIDE - fluoride tablet, chewable

  • 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 May 21, 2011

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  • DESCRIPTION

    Active Ingredient: 1 mg of fluoride ion from 2.2 mg of sodium fluoride (NaF).

    Inactive Ingredients: Lactose, Saccharine, Cherry Flavor, D&C Red #7 Calcium Lake, 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)

    743634

    Manufactured for:
    Libertas Pharma, Inc.
    Lawrenceville, GA 30043
    Iss. 03/11   172-12

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  • Container Label

    NDC 51862-172-12

    Fluoride Chewable Tablets

    1 mg

    (From 2.2 mg of Sodium Fluoride)

    Cherry Flavor       120 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:51862-172
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1 mg
    Inactive Ingredients
    Ingredient Name Strength
    CHERRY (UNII: BUC5I9595W)  
    LACTOSE (UNII: J2B2A4N98G)  
    SACCHARIN (UNII: FST467XS7D)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Color RED Score no score
    Shape ROUND Size 6mm
    Flavor CHERRY Imprint Code 172
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51862-172-12 120 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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