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

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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 IU40%20%
    Vitamin C (as Ascorbic Acid)35 mg88%58%
    Vitamin D3 (as Cholecalciferol)400 IU100%100%
    Vitamin E (as D-Alpha-Tocopheryl Acetate)5 IU50%17%
    Thiamin (as Thiamine HCl, Vitamin B1)0.5 mg71%33%
    Riboflavin (Vitamin B2)0.6 mg75%35%
    Niacin (as Niacinamide)0.8 mg9%4%
    Vitamin B6 (as Pyridoxine HCl)0.4 mg57%20%
    Folate (as 65 mcg Quatrefolic® ((6S-5-methyltetrahydrofolic acid, glucosamine salt*, molar equivalent to 35 mcg of Folic Acid))35 mcg18%9%
    Vitamin B12 (as Cyanocobalamin)2 mcg67%33%
    Magnesium (as Magnesium Oxide)10 mg5%3%
    Copper (as Cupric Sulfate)1 mg100%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.

  • INDICATIONS AND USAGE

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

  • 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.

  • 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.

  • WARNINGS

    Keep out of the 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)*
    AgeLess than 0.3ppm0.3-0.6 ppmGreater 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 monthsNoneNoneNone
    6 months-3 years0.25 mg/dayNoneNone
    3-6 years0.50 mg/day0.25 mg/dayNone
    6-16 years1.0 mg/day0.50 mg/dayNone

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

  • DESCRIPTION

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

  • 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.

  • 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

  • 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
  • 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:15370-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1000 [iU]  in 1 mL
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID35 mg  in 1 mL
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [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) THIAMINE0.5 mg  in 1 mL
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN0.6 mg  in 1 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.8 mg  in 1 mL
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE0.4 mg  in 1 mL
    LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID35 ug  in 1 mL
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN2 ug  in 1 mL
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE10 mg  in 1 mL
    CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION1 mg  in 1 mL
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GRAPE (UNII: 6X543N684K)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15370-100-501 in 1 CARTON07/15/2014
    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 OTHER07/15/2014
    Labeler - CarWin Pharmaceutical Associates, LLC (079217215)