Label: FLORIVA- vitamin a acetate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol, thiamine, riboflavin, niacinamide, pyridoxine, levomefolate glucosamine, folic acid, cyanocobalamin, biotin, zinc gluconate, cupric oxide, and sodium fluoride tablet, chewable

  • NDC Code(s): 52796-177-90
  • Packager: BonGeo Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Updated February 1, 2024

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  • SPL UNCLASSIFIED SECTION

    Supplement Facts
    Serving Size: 1 tablet
    Servings Per Container: 90
    Amount per tablet% Daily Value*
    *
    Percent Daily Value (%DV) for Adults and Children 4 or more years of age based on a 2000 calorie diet.
    †
    Daily Value not established.
    Vitamin A (50% beta carotene/50% acetate)2000 IU40%
    Vitamin C (ascorbic acid)75 mg125%
    Vitamin D3 (cholecalciferol)600 IU150%
    Vitamin E (dl alpha tocopherol acetate)20 IU67%
    Vitamin B1 (thiamine)1.3 mg87%
    Vitamin B2 (riboflavin)1.5 mg88%
    Niacin (nicotinamide)15 mg75%
    Vitamin B6 (pyridoxine)1.8 mg90%
    Folate (as 300 mcg Quatrefolic R ((6S-5-methyltetrahydrofolic acid, glucosamine salt†, molar equivalent to 162 mcg of folic acid) and 100 mcg of folic acid) Quatrefolic CAS #: 1181972-37-1262 mcg 66%
    Vitamin B12 (cyanocobalamin)6 mcg100%
    Biotin40 mcg13%
    Zinc (zinc gluconate)5 mg33%
    Copper (cupric oxide)1 mg50%
    Fluoride (sodium fluoride)1 mg†
  • Other Ingredients

    Natural berry flavor, bitterness masking agent, MCC, sucralose, talc, magnesium stearate, xylitol (DC and regular grade).

  • Description

    Off-white to pale yellow, speckled, berry flavored, hexagon shaped chewable tablet. Debossed "177" on one side and scored on the other.

  • Directions

    USE AS DIRECTED BY YOUR PHYSICIAN.

  • Tamper Evident Feature

    Do not use if inner-seal beneath cap is missing or broken.

  • WARNING

    KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222. TABLET SHOULD BE CHEWED. THIS TABLET, AS WITH ALL TABLETS, IS NOT RECOMMENDED FOR CHILDREN UNDER AGE OF 4 DUE TO RISK OF CHOKING.

  • CAUTION

    Do not use this product if you are allergic to any of the ingredients. Take this product at least 2 hours before or after taking any products containing calcium (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives). Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis. Account for all daily sources of fluoride intake.

  • OTHER INFORMATION

    You may report serious side effects to 1-844-640-7607. Store in a cool, dry place at room temperature 20-25º Celsius (68-77º Fahrenheit) away from heat and sunlight. Store in original container.

    The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health insurance and state level reimbursement programs and is not intended to denote registration with the FDA.

    The manufacturer of this product requires that it be dispensed only under the order of a physician or licensed medical practitioner.

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    BonGeo Pharmaceuticals, Inc.
    Roseland, NJ 07068

    Manufactured by:
    Sancilio & Co., Inc.
    Riviera Beach, FL 33404

    LOT/EXP

    Quatrefolic Trademark and Patent property of Gnosis SpA.

  • PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

    1 mg*
    FLUORIDE
    TABLETS

    BonGeo™
    PHARMACEUTICALS

    52796-177-90

    Floriva™
    1 mg TABLETS

    Chewable Fluoride Multivitamin

    Quatrefolic®

    Patent Ref.: U.S. Patent No. 7,947,662;
    Other patents pending

    Natural Berry Flavor

    Rx Dietary Supplement

    90 Chewable Tablets

    *contains 1 mg fluoride
    from 2.2 mg sodium fluoride

    • SUGAR FREE AND GLUTEN FREE • NO ARTIFICIAL COLORS OR DYES •

    PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    FLORIVA 
    vitamin a acetate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol, thiamine, riboflavin, niacinamide, pyridoxine, levomefolate glucosamine, folic acid, cyanocobalamin, biotin, zinc gluconate, cupric oxide, and sodium fluoride tablet, chewable
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52796-177
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1000 [iU]
    BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE1000 [iU]
    Ascorbic acid (UNII: PQ6CK8PD0R) (Ascorbic acid - UNII:PQ6CK8PD0R) Ascorbic acid75 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL600 [iU]
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL20 [iU]
    THIAMINE (UNII: X66NSO3N35) (Thiamine Ion - UNII:4ABT0J945J) THIAMINE1.3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) RIBOFLAVIN1.5 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE15 mg
    PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE1.8 mg
    LEVOMEFOLATE GLUCOSAMINE (UNII: Q65PL71Q1A) (LEVOMEFOLATE GLUCOSAMINE - UNII:Q65PL71Q1A) LEVOMEFOLATE GLUCOSAMINE162 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID100 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN6 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN40 ug
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE5 mg
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION1 mg
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorWHITE (Off white, speckled) Score2 pieces
    ShapeHEXAGON (6 SIDED)Size13mm
    FlavorBERRYImprint Code 177
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52796-177-9090 in 1 BOTTLE; Type 0: Not a Combination Product10/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER10/15/2014
    Labeler - BonGeo Pharmaceuticals, Inc. (964822022)
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