Label: MULTIVITAMIN WITH FLUORIDE- vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, and sodium fluoride tablet, chewable

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated February 3, 2020

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

  • DOSAGE AND ADMINISTRATION

    One tablet daily or as directed by a physician.

  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size 1 Tablet
    Servings Per Container 100
    Amount Per Serving% Daily Value
    *
    Daily Value not established
    Vitamin A2500 IU50%
    Vitamin C60 mg100%
    Vitamin D400 IU100%
    Vitamin E15 IU50%
    Thiamine1.05 mg70%
    Riboflavin1.2 mg70%
    Niacinamide13.5 mg68%
    Vitamin B61.05 mg53%
    Folic Acid0.3 mg75%
    Vitamin B124.5 mcg75%
    Fluoride0.5 mg*
  • WARNING

    KEEP OUT OF THE REACH OF CHILDREN.

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • HEALTH CLAIM

    Other Ingredients: Artificial cherry flavor, artificial grape flavor, ascorbic acid, cholecalciferol, compressible sugar, D&C Red #7 calcium lake, FD&C Blue #1 aluminum lake, FD&C Yellow #6 aluminum lake, folic acid, magnesium stearate, microcrystalline cellulose, natural and artificial orange flavor, niacinamide, polyethylene glycol, pyridoxine HCI, riboflavin, sodium ascorbate, sodium fluoride, stearic acid, sucralose, thiamine HCI, vitamin A acetate, vitamin B12 and vitamin E acetate.

    Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.

  • CLINICAL PHARMACOLOGY

    Significant decrease in the incidence of dental caries can be linked to the fluoridation of the water supply (1ppm fluoride) during the period of tooth development.

    MultiVitamin with 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:

    Ca10(PO4)6(OH2) + 2F-Ca10 (PO4)6F2 + 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 of saliva.
  • DIETARY SUPPLEMENTATION

    Multivitamins with fluoride offer supplementation of the diet with 10 vitamins and fluoride.

  • WARNINGS

    AS IN THE CASE OF ALL MEDICATIONS, KEEP OUT OF THE REACH OF CHILDREN. This tablet should be chewed. This product, as with all chewable tablets are not recommended for children under the age of 4 due to risk of choking.

  • PRECAUTIONS

    The suggested dose of MultiVitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

    Before recommending MultiVitamin with 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.

    To report SUSPECTED ADVERSE REACTIONS, contact H2-Pharma, LLC at 1 (866) 592-6438 or FDA at 1 (800) 332-1088 or via the web at www.fda.gov/medwatch/index.html for voluntary reporting of adverse reactions.

  • DOSAGE AND ADMINISTRATION

    One tablet daily or as directed by a physician.

  • HOW SUPPLIED

    MultiVitamin with Fluoride Chewable Tablets 0.25 mg are available as orange, red and purple chewable tablets imprinted with "151" in 100 tablet bottles.

    MultiVitamin with Fluoride Chewable Tablets 0.5 mg are available as orange, red and purple chewable tablets imprinted with "152" in 100 tablet bottles.

    MultiVitamin with Fluoride Chewable Tablets 1.0 mg are available as orange, red and purple chewable tablets imprinted with "153" in 100 tablet bottles.

    STORAGE

    Store at controlled room temperature 20ºC-25ºC (68º-77ºF), excursions permitted between 15º-30ºC (59º-86ºF) [See USP].

  • HEALTH CLAIM

    Distributed by:
    H2-Pharma, LLC
    2010 Berry Chase Place
    Montgomery, AL 36117
    www.h2-pharma.com

    1067085

  • PRINCIPAL DISPLAY PANEL - 0.5 mg Tablet Bottle Label

    61269-152-01

    MultiVitamin
    with Fluoride
    Chewable Tablets

    0.5 mg
    MultiVitamin and Fluoride Supplement

    Dietary Supplement

    100 Tablets

    H2pharma

    PRINCIPAL DISPLAY PANEL - 0.5 mg Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    MULTIVITAMIN WITH FLUORIDE 
    vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, and sodium fluoride tablet, chewable
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:61269-152
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A2500 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE15 [iU]
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE1.05 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.2 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE13.5 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE1.05 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID0.3 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN4.5 ug
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CHERRY (UNII: BUC5I9595W)  
    GRAPE (UNII: 6X543N684K)  
    SUCROSE (UNII: C151H8M554)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    ORANGE (UNII: 5EVU04N5QU)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:61269-152-01100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT12/05/2016
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    color
    color
    scoring1
    shape
    size (solid drugs)13 mm
    imprint
    flavor
    flavor
    flavor
    Labeler - H2-Pharma, LLC (028473634)