Label: FLUORIDE - sodium fluoride tablet, chewable

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 05/11

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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 LABEL Item Code (Source) NDC:51862-172
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1 mg
    Inactive Ingredients
    Ingredient Name Strength
    CHERRY  
    LACTOSE  
    SACCHARIN  
    D&C RED NO. 7  
    MAGNESIUM STEARATE  
    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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