Label: FLORAFOL- multivitamin and fluoride supplement tablet

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

Drug Label Information

Updated June 10, 2024

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

  • FloraFol

    (Multivitamin with 1.0 mg of Fluoride) Chewable Tablet

  • Multivitamin and Fluoride Supplement

    Multivitamin and Fluoride Supplement

    Supplement Facts
    Serving Size: 1 Tablet
    Servings Per Cotainer: 30
    % Daily Values
    Amount Per Serving%DV Children 4-8 years%DV Children
     9 years and older
    Vitamin A (as Retinyl Acetate) 700 mcg175%117%
    Vitamin B1 (as Thiamine Mononitrate)1 mg167%111%
    Vitamin B2 (as Riboflavin )1 mg167%111%
    Niacin (as Niacinamide)12 mg150%100%
    Vitamin B6 (as Pyridoxine HCl)1 mg192%115%
    Vitamin B12 (as Cyancobalamin)3.5 mcg292%194%
    Folate (as L-Methylfolate, Calcium Salt Metafolin)250 mcg DFE125%83%
    Vitamin C (as Sodium Ascorbate)70 mg280%156%
    Vitamin D (as Cholecalciferol) 12 mcg80%80%
    Vitamin E (as D-Alpha-Tocopherol) 11.5 mg164%105%
    Fluoride (as Sodium Fluoride)1.0 mg100%50%

    Other Ingredients: Xylitol, Sorbitol, Citric Acid Anhydrous, Stevia/Monk Fruit, Berry Flavor, Beet Root Juice, Carrageenan, Magnesium Stearate, Stearic Acid

    Allergens: Fish Oil

  • DOSAGE & ADMINISTRATION

    Caution: This product should be chewed and is not recommended for children under age 4 due to risk of choking.

  • SAFE HANDLING WARNING

    Distributed by:
    Pangea Pharmaceuticals, LLC
    Brielle, NJ 08730
    1-855-892-8224
    www.florafol.com

  • PRINCIPAL DISPLAY PANEL - Multivitamin with 1.0 mg of Fluoride

    81279-103-30

    FloraFol

    (Multivitamin with 1.0 mg of Fluoride) Chewable Tablet MULTIVITAMIN & FLUORIDE SUPPLEMENT BERRY FLAVOR

    1.0 mg

    30 Tablets

    103-30

  • INGREDIENTS AND APPEARANCE
    FLORAFOL 
    multivitamin and fluoride supplement tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:81279-103
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A700 ug
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE12 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE1.15 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN3.5 ug
    LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID250 ug
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID70 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL12 ng
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-11.5 mg
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITOL (UNII: 506T60A25R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:81279-103-301 in 1 PACKAGE
    130 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement06/10/2024
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    size (solid drugs)11 mm
    scoring1
    flavor
    Labeler - Pangea Pharmaceuticals, LLC (117751012)
    Registrant - Pangea Pharmaceuticals, LLC (117751012)