Label: FLUORITAB CHEWABLE CHERRY- sodium fluoride tablet, chewable

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

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Drug Label Information

Updated October 29, 2012

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  • ACTIVE INGREDIENT

    CONTAINS: 2.2 MG SODIUM FLUORIDE

    EACH TABLET CONTAINS 1 MG FLUORIDE

  • DOSAGE & ADMINISTRATION

    PPM FLUORIDE IONDAILY DOSAGE

    IN DRINKING WATERAGE 6 MO. – 3 YRS.AGE 3-6 YRS.AGE 6-16 YRS.

    LESS THAN 0.3 PPM0.25 MG 0.50 MG1 MG

    0.3 TO 0.6 PPMNONE 0.25 MG 0.50 MG

    OVER 0.6 PPMNONENONENONE

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.
  • WARNINGS

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

  • INDICATIONS & USAGE

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

  • INACTIVE INGREDIENT

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

  • WARNINGS AND PRECAUTIONS

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

  • PRINCIPAL DISPLAY PANEL

    Fluoritab Chewable Cherry Tablets (1mg)_1000-ct

  • INGREDIENTS AND APPEARANCE
    FLUORITAB CHEWABLE  CHERRY
    sodium fluoride tablet, chewable
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0288-2203
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0288-2203-01100 in 1 BOTTLE
    2NDC:0288-2203-101000 in 1 BOTTLE
    3NDC:0288-2203-025000 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/09/2011
    Labeler - Fluoritab Corporation (005376702)
    Registrant - Fluoritab Corporation (005376702)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medical Products Laboratories002290302manufacture(0288-2203)
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