Label: LUDENT- sodium fluoride tablet, chewable 

  • NDC Code(s): 44946-1009-3, 44946-1009-9
  • Packager: Sancilio & Company Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 12/11

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

  • SPL UNCLASSIFIED SECTION

    Each 0.5 mg Fluoride Tablet Contains:

    *
    Each 0.5 mg Fluoride Tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride (NaF).
    Fluoride (as Sodium Fluoride)* 0.5 mg
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  • WARNING

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222. TABLET SHOULD BE CHEWED. THIS PRODUCT, AS WITH ALL CHEWABLE TABLETS, IS NOT RECOMMENDED FOR CHILDREN UNDER AGE 4 DUE TO RISK OF CHOKING.

    DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING

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  • Directions

    USE AS DIRECTED BY YOUR PHYSICIAN.

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  • Description

    White to off-white, orange flavor, round-shaped chewable tablet debossed "SCI" on one side and "1007" on the other.

    See inside panel for additional information

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  • Caution

    Do not use this product if you are allergic to any of the ingredients. Take this product at least 2 hours before or after taking any products containing calcium (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives). Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis. Account for all daily sources of fluoride intake.

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  • Other Ingredients

    Xylitol, microcrystalline cellulose, malic acid, magnesium stearate, talc, citric acid, natural orange flavor, sucralose.

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  • Storage

    Store in a cool, dry place at room temperature 20° - 25°C (68° - 77°F) away from heat and sunlight. Store in original container.

    This medical food product is formulated to be administered orally, under the ongoing supervision of a physician and is intended for the dietary management of dental caries for which a distinctive nutritional requirement of fluoride, based on recognized scientific principles, has been established by medical evaluation.

    The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health-insurance and state level reimbursement programs and is not intended to denote registration with the FDA.

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  • SPL UNCLASSIFIED SECTION

    Manufactured by: Sancilio & Co., Inc.
    Riviera Beach, FL 33404 USA

    rev. 12/02/11

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  • PRINCIPAL DISPLAY PANEL - 0.5 mg Bottle Label

    SCI
    Sancilio &
    Company, Inc.

    Developing Good Science into Great Medicine

    44946-1009-9
    Rx Only

    Ludent®-Fluoride
    Chews
    Sodium Fluoride Chewable Tablets

    NO DYES, ARTIFICIAL FLAVORS OR SUGAR
    SACCHARIN AND GLUTEN FREE
    CONTAINS XYLITOL

    0.5
    mg*

    1000 tablets

    Made in U.S.A.

    PRINCIPAL DISPLAY PANEL - 0.5 mg Bottle Label
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  • INGREDIENTS AND APPEARANCE
    LUDENT 
    sodium fluoride tablet, chewable
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44946-1009
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (Fluoride Ion) Sodium Fluoride 0.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    Xylitol  
    Cellulose, Microcrystalline  
    Malic Acid  
    Magnesium Stearate  
    Talc  
    Anhydrous Citric Acid  
    Sucralose  
    Product Characteristics
    Color WHITE (White to off white) Score score with uneven pieces
    Shape ROUND Size 13mm
    Flavor ORANGE Imprint Code SCI;1007
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:44946-1009-3 24 in 1 BOX
    1 120 in 1 BOTTLE
    2 NDC:44946-1009-9 12 in 1 BOX
    2 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 12/20/2011
    Labeler - Sancilio & Company Inc (176681257)
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