Label: QUFLORA PEDIATRIC DROPS- vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, levomefolic acid, cyanocobalamin, magnesium oxide, cupric sulfate, and sodium fluoride liquid

  • NDC Code(s): 15370-100-50
  • Packager: CarWin Pharmaceutical Associates, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 3, 2017

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  • SPL UNCLASSIFIED SECTION

    Supplement Facts
    Serving Size: 1 mL
    Servings Per Container: 50
    Amount Per 1 mL % Daily Value Children 6 months to under 4 years of age % Daily Value for Adults and Children 4 or more years of age
    *
    Daily Value (DV) not established
    Vitamin A (as Acetate) 1,000 IU 40% 20%
    Vitamin C (as Ascorbic Acid) 35 mg 88% 58%
    Vitamin D3 (as Cholecalciferol) 400 IU 100% 100%
    Vitamin E (as D-Alpha-Tocopheryl Acetate) 5 IU 50% 17%
    Thiamin (as Thiamine HCl, Vitamin B1) 0.5 mg 71% 33%
    Riboflavin (Vitamin B2) 0.6 mg 75% 35%
    Niacin (as Niacinamide) 0.8 mg 9% 4%
    Vitamin B6 (as Pyridoxine HCl) 0.4 mg 57% 20%
    Folate (as 65 mcg Quatrefolic® ((6S-5-methyltetrahydrofolic acid, glucosamine salt*, molar equivalent to 35 mcg of Folic Acid)) 35 mcg 18% 9%
    Vitamin B12 (as Cyanocobalamin) 2 mcg 67% 33%
    Magnesium (as Magnesium Oxide) 10 mg 5% 3%
    Copper (as Cupric Sulfate) 1 mg 100% 50%
    Fluoride (as Sodium Fluoride) 0.25 mg * *

    Other Ingredients: Purified Water, Carrageenan, Sorbitol, Propylene Glycol, Glycerin, Grape Flavor, Potassium Sorbate, Sodium Benzoate, Citric Acid and Sucralose.

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  • INDICATIONS AND USAGE

    Quflora® 0.25 mg/mL F* Pediatric Drops is a prescription dietary supplement providing essential vitamins, minerals and fluoride.

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  • CONTRAINDICATIONS

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

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  • 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 Carwin Pharmaceutical Associates, LLC at 1-844-700-5011.

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  • WARNINGS

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

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  • 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
    *
    1.0 part per million (ppm) = 1 milligram/liter (mg/L)
    2.2 mg sodium fluoride contains 1 mg fluoride ion
    Birth-6 months None None None
    6 months-3 years 0.25 mg/day None None
    3-6 years 0.50 mg/day 0.25 mg/day None
    6-16 years 1.0 mg/day 0.50 mg/day None

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

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  • DESCRIPTION

    Quflora® 0.25 mg/mL F* Pediatric Drops is a light brown, dye free, grape flavored liquid.

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  • HOW SUPPLIED

    Quflora® 0.25 mg/mL F* Pediatric Drops in 50 mL (1 2/3 FL. OZ.) child-resistant bottles with accompanying calibrated dropper (Product Code: 15370-100-50).

    Rx Only

    STORAGE

    Store at controlled room temperature 20°C to 25°C (68°F to 77°F). Protect from light, moisture and heat.

    SHAKE BEFORE USING

    TAMPER EVIDENT: Do not use if seal is broken or missing.

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  • SPL UNCLASSIFIED SECTION

    Quatrefolic® is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1

    Manufactured for:

    Carwin Pharmaceutical Associates, LLC

    Hazlet, NJ 07730

    CAR-100-02
    Rev. 5/17

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  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

    15370-100-50

    QUfLORA™
    PEDIATRIC
    Liquid Drops

    Dietary Supplement
    0.25 mg/mL Fluoride

    Each dropperful (1 mL) contains:
    0.55 mg sodium fluoride, USP

    Rx Only • Grape Flavor

    50 mL
    (1⅔ fl oz.)

    carwin
    PHARMACEUTICAL ASSOCIATES

    Quatrefolic®

    PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    QUFLORA PEDIATRIC DROPS 
    vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, levomefolic acid, cyanocobalamin, magnesium oxide, cupric sulfate, and sodium fluoride liquid
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15370-100
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 1000 [iU]  in 1 mL
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 35 mg  in 1 mL
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU]  in 1 mL
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D- 5 [iU]  in 1 mL
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 0.5 mg  in 1 mL
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 0.6 mg  in 1 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 0.8 mg  in 1 mL
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 0.4 mg  in 1 mL
    LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID 35 ug  in 1 mL
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 2 ug  in 1 mL
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 10 mg  in 1 mL
    CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 1 mg  in 1 mL
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GRAPE (UNII: 6X543N684K)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color BROWN Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:15370-100-50 1 in 1 CARTON 07/15/2014
    1 50 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 07/15/2014
    Labeler - CarWin Pharmaceutical Associates, LLC (079217215)
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