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 Item Code (Source) NDC:0288-1106
    Route of Administration ORAL DEA Schedule     
    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
    LACTOSE (UNII: J2B2A4N98G)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    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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