Label: FLUORITAB CHEWABLE CHERRY- sodium fluoride tablet, chewable

  • NDC Code(s): 0288-1106-01, 0288-1106-02, 0288-1106-10
  • Packager: Fluoritab Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 10/12

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  • ACTIVE INGREDIENT

    CONTAINS: 1.1 MG SODIUM FLUORIDE

    EACH TABLET CONTAINS 0.5 MG FLUORIDE

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

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  • WARNINGS

    CAUTION: FEDERAL (U.S.A.) LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.

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  • INDICATIONS & USAGE

    DIRECTIONS: ONE TABLET PER DAY, CHEWED OR PARTIALLY DISSOLVED IN MOUTH BEFORE SWALLOWING, PREFERABLY AT NIGHT AFTER BRUSHING TEETH.

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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: LACTOSE, FLAVOR, SACCHARIN SODIUM, MAGNESIUM STEARATE

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  • WARNINGS AND PRECAUTIONS

    PRECAUTION -RECOMMEND DOSAGE ON CHART BELOW SHOULD NOT BE EXCEEDED AS PROLONGED OVERDOSE MAY RESULT IN DENTAL FLUOROSIS.

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  • INGREDIENTS AND APPEARANCE
    FLUORITAB CHEWABLE  CHERRY
    sodium fluoride tablet, chewable
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0288-1106
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE  
    SACCHARIN SODIUM ANHYDROUS  
    MAGNESIUM STEARATE  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0288-1106-01 100 in 1 BOTTLE
    2 NDC:0288-1106-10 1000 in 1 BOTTLE
    3 NDC:0288-1106-02 5000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/09/2011
    Labeler - Fluoritab Corporation (005376702)
    Registrant - Fluoritab Corporation (005376702)
    Establishment
    Name Address ID/FEI Business Operations
    Medical Products Laboratories 002290302 manufacture(0288-1106)
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