Label: MULTIVITAMIN WITH FLUORIDE- 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 April 3, 2020

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  • MULTIVITAMIN WITH FLUORIDE vitamin A, ascorbic acid, sodium ascorbate, cholecalciferol, alpha-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid and cyanocobalamin tablet, chewable

    Each Fluoride Chewable Tablet Contains:

    Supplement Facts


    Dosage Size 1 Chewable Tablet

    Amount per tablet 1.0 mg %DV Adults and Children 4 years or More


    Vitamin A 750 ug 50%

    Vitamin C 60 mg 100%

    VItamin D 10 ug 100%

    Vitamin E 13 mg 50%

    Thiamine 1.05 mg 70%

    Riboflavin 1.2 mg 71%

    Niacin 13.5 mg 68%

    Vitamin B 6 1.05 mg 53%

    Folate 300 ug 75%

    Vitamin B 12 4.5 ug 75%

    Fluoride 1.0 mg *

    *daily value (DV) not established

    Multivitamin with Fluoride 1 mg active ingredient for caries prophylaxis: Fluoride as sodium fluoride

    Multivitamin with 1 mg Fluoride Chewable Tablets

    provide sodium fluoride and ten essential vitamins in a chewable tablet.

    Other ingredients: ascorbic acid, cholecalciferol, compressible sugar, croscarmellose sodium, dl-alpha tocopheryl acetate, D and C Red #27 aluminum lake, FD and C Blue #1 aluminum lake, folic acid, grape flavor, magnesium stearate, microcrystalline cellulose, niacinamide, pyridoxine, riboflavin, sodium ascorbate, stearic acid, thiamine, vitamin A, vitamin B 12.

  • CLINICAL PHARMACOLOGY

    It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries.

    Multivitamin with 1.0 mg Fluoride Chewable Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride.

    Hydroxyapatite

    is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal,

    fluorapatite

    . The reaction may be expressed by the equation:

    Ca 10(PO 4) 6(OH) 2 + 2F- ------- Ca 10(PO 4) 6F 2 + 2OH-

    (Hydroxyapatite) (Fluorapatite)

    Three stages of fluoride deposition in tooth enamel can be distinguished:

    1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.

    2. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.

    3. After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.

  • INDICATIONS AND USAGE

    Supplementation of the diet with ten essential vitamins.

    Supplementation of the diet with fluoride for caries prophylaxis.


    Multivitamin with 1.0 mg Fluoride Chewable Tablets

    provide 1.0 mg fluoride in tablet form for children 6-16 years of age in areas where the water fluoride level is less than 0.3 ppm.


    Multivitamin with 1.0 mg Fluoride Chewable Tablets

    supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B 6, vitamin B 12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride.

    The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplements.

    Children using

    Multivitamin with 1.0 mg Fluoride Chewable Tablets

    regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.

    Multivitamin with Fluoride Chewable Tablets is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.

  • WARNING

    Keep out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.


    Caution: Do not eat or drink dairy products within one hour of fluoride administration.

    Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.








  • PRECAUTION

    The suggested dose of

    Multivitamin with 1.0 mg Fluoride Chewable Tablets

    should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

    Before prescribing

    Multivitamin with 1.0 mg Fluoride Chewable Tablets:


    1. Determine the fluoride content of the drinking water from all major sources.

    2. Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste.

    3. Periodically check to make sure that the child does not develop significant dental fluorosis.

  • ADVERSE REACTIONS

    Allergic rash and other idiosyncrasies have been rarely reported.

  • DOSAGE AND ADMINISTRATION

    One tablet daily, to be dissolved in the mouth or chewed before swallowing. Do not give a chewable tablet to a child younger than 4 years old.

  • HOW SUPPLIED

    Multivitamin chewable tablets containing 1 mg fluoride are purple-colored, grape flavor, un-scored, round debossed "109" tablets are available on prescription only in bottles of 100 tablet bottles. NDC: 59088-109-59.



  • STORAGE

    Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.

    Dispense in a tight, light resistant container with a child-resistant closure as defined in the USP/NF. All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

  • Base Label

    Base

  • Inside Label

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  • Outside label

    Fornt

  • INGREDIENTS AND APPEARANCE
    MULTIVITAMIN WITH FLUORIDE 
    sodium fluoride tablet, chewable
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-109
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg
    VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A750 ug
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID24 mg
    SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID36 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-13.5 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.05 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.2 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN13.5 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE1.05 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID300 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN4.5 ug
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ASPARTAME (UNII: Z0H242BBR1)  
    Product Characteristics
    Colorpurple (Dark purple) Scoreno score
    ShapeROUNDSize13mm
    FlavorGRAPE (Grape flavor) Imprint Code 109
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-109-59100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2011
    Labeler - PureTek Corporation (785961046)
    Establishment
    NameAddressID/FEIBusiness Operations
    PureTek Corporation785961046manufacture(59088-109) , label(59088-109) , pack(59088-109) , relabel(59088-109) , repack(59088-109)