Label: FLORAFOL FE PEDIATRIC 0.25 MG/ML MULTIVITAMIN AND FLUORIDE LIQUID DROPS (vitamin a (as retinyl palmitate) vitamin c (as ascorbic acid) vitamin d3 (as cholecalciferol) vitamin e (as d-alpha-tocopherol acetate) vitamin b1 (as thiamine hcl) vitamin b2 (as riboflavin phosphate sodium) niacin (as niacinamide) vitamin b6 (pyridoxine hcl) folate (as 69 mcg quatrefolic ((6s)-5 methyltetrahydrofolate, glucosamine salt, molar equivalent to 37.5 mcg of folic acid)) vitamin b12 (as cyanocobalamin) iron (as ferrous sulfate) fluoride- as sodium fluoride solution/ drops

  • NDC Code(s): 81279-101-50
  • Packager: Pangea Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated December 22, 2023

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  • DESCRIPTION

    Supplement Facts
    Serving Size : 1mL
    Servings per container: 50

    % Daily Value

    Amount per serving 1mL

    Infants 7-12 months

    Children
    1-3 yrs

    Children
    4-8 yrs

    VITAMIN A (as Retinyl Palmitate)

    450 mcg

    90%

    150%

    113%

    VITAMIN C (as Ascorbic Acid)

    36 mg

    72%

    240%

    144%

    VITAMIN D3 (as Cholecalciferol)

    10 mcg

    100%

    67%

    67%

    VITAMIN E (as d-Alpha-Tocopherol Acetate)

    3.35 mg

    45%

    38%

    32%

    VITAMIN B1 (as Thiamine HCl) 

    0.5 mg

    167%

    100%

    83%

    VITAMIN B2 (as Riboflavin Phosphate Sodium)

    0.6 mg

    150%

    120%

    100%

    NIACIN (as Niacinamide)

    4 mg

    100%

    67%

    50%

    VITAMIN B6 (Pyridoxine HCl)

    0.4 mg

    133%

    80%

    67%

    Folate (as 69 mcg Quatrefolic® 
    ((6S)-5 Methyltetrahydrofolate, glucosamine salt, molar equivalent to 37.5 mcg of Folic Acid))

    117 mcg DFE

    147%

    78%

    59%

    VITAMIN B12 (as Cyanocobalamin)

    2 mcg

    400%

    222%

    167%

    Iron (as Ferrous Sulfate)   

    		9.5 mg  86%136%95%

    FLUORIDE (as Sodium Fluoride) 

    0.25 mg

    50%

    36%

    25%

    Other Ingredients: Purified Water, Glycerin, Sorbitol, Sucralose, Sodium Benzoate, Potassium Sorbate, Sodium Carbonate, Monoammonium glycyrrhizinate, Grape Flavor.

  • INDICATIONS AND USAGE

    Florafol™ FE Pediatric 0.25 mg/mL Fluoride (with Iron), is a multivitamin and fluoride prescription product providing essential vitamins, minerals and fluoride.

  • CONTRAINDICATIONS

    Do not use in areas where drinking water exceeds 0.6 ppm Fluoride. Do not administer to pediatric patients less than 6 months old.

  • PRECAUTIONS

    General

    Do not use this product if you are allergic to any of the ingredients. The suggested dose should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride. Do not eat or drink dairy products within one hour of fluoride administration since these may decrease effectiveness.

    Folic Acid

    Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

    Other Information

    Call your doctor for medical advice about side effects. You may report serious side effects by calling Pangea Pharmaceuticals, LLC, at 1-855-892-8224.

    WARNINGS

    Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, seek professional emergency assistance or contact a Poison Control Center immediately.

  • DOSAGE AND ADMINISTRATION

    See schedule below to determine dosage. Administer orally as prescribed by a healthcare practitioner. Use with calibrated dropper for measuring doses.

    Fluoride Ion Level In Drinking Water (ppm)*

    Age

    Less than 0.3ppm

    0.3-0.6 ppm

    Greater than 0.6 ppm

    Birth-6 months

    6 months-3 years

    3-6 years

    None

    0.25 mg/day†

    0.50 mg/day†

    None

    None

    0.25 mg/day

    None

    None

    None

    6-16 years

    1.0 mg/day

    0.50 mg/day

    None

    * 1.0 part per million (ppm) = 1 milligram/liter (mg/L)

    † 2.2 mg sodium fluoride contains 1 mg fluoride ion

    Dietary Fluoride Supplement dosing schedule approved by the American Dental Association (ADA), American Academy of Pediatrics (AAP) & American Academy of Pediatric Dentistry (AAPD).

  • DESCRIPTION

    Florafol™ FE Pediatric 0.25 mg/mL Fluoride (with Iron), multivitamin and fluoride liquid drops is a dye free and gluten free grape flavored product.

  • HOW SUPPLIED

    Florafol™ FE Pediatric 0.25 mg/mL Fluoride is supplied in 50 mL (1-2/3 fl. oz.) child-resistant bottles with accompanying calibrated dropper (Product Code: 81279-101-50).

    Rx Only

    STORAGE

    Store in a cool, dry place at room temperature 68 °F to 77 °F (20 °C to 25 °C) away from direct heat and sunlight.
    Do not refrigerate this product.

    SHAKE WELL BEFORE USE

    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) since these may decrease effectiveness. Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis.

  • TAMPER EVIDENT

    Do not use if seal is broken or missing.

  • SPL UNCLASSIFIED SECTION

    Quatrefolic® is a registered trademark of Gnosis, SpA.


    Manufactured for:
    Pangea Pharmaceuticals, LLC,
    Brielle, NJ 08730

    Rev 12/2023

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

    label

    carton

    81279-101-50
    Florafol ™ FE
    PEDIATRIC
    Multivitamin & Fluoride Liquid Drops
    0.25 mg/mL Fluoride
    Dye Free • Gluten Free
    Rx Only • Grape Flavor
    50 mL
    (1⅔ fl oz.)

  • INGREDIENTS AND APPEARANCE
    FLORAFOL FE PEDIATRIC 0.25 MG/ML MULTIVITAMIN AND FLUORIDE LIQUID DROPS 
    vitamin a (as retinyl palmitate) vitamin c (as ascorbic acid) vitamin d3 (as cholecalciferol) vitamin e (as d-alpha-tocopherol acetate) vitamin b1 (as thiamine hcl) vitamin b2 (as riboflavin phosphate sodium) niacin (as niacinamide) vitamin b6 (pyridoxine hcl) folate (as 69 mcg quatrefolic ((6s)-5 methyltetrahydrofolate, glucosamine salt, molar equivalent to 37.5 mcg of folic acid)) vitamin b12 (as cyanocobalamin) iron (as ferrous sulfate) fluoride (as sodium fluoride) solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:81279-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A450 ug  in 1 mL
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID36 mg  in 1 mL
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug  in 1 mL
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL3.35 mg  in 1 mL
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE0.5 mg  in 1 mL
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN0.6 mg  in 1 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE4 mg  in 1 mL
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE0.4 mg  in 1 mL
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID117 ug  in 1 mL
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN2 ug  in 1 mL
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.25 mg  in 1 mL
    FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION9.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA)  
    .ALPHA.-D-GLUCURONIC ACID (UNII: M7Y086VB5G)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorgrapeImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81279-101-501 in 1 CARTON12/20/2023
    150 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/20/2023
    Labeler - Pangea Pharmaceuticals, LLC (117751012)
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