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

  • NDC Code(s): 15370-103-30, 15370-104-30, 15370-105-30
  • 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 March 14, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Supplement Facts
    Serving Size: 1 Tablet
    Servings per Container: 30
    Amount
    per Serving
    % Daily
    Value*
    *
    %Daily Value for Adults and Children 4 or more years of age
    Daily Value not established
    Vitamin A (as Acetate) 1,200 IU 24%
    Vitamin C (as Ascorbic Acid) 60 mg 100%
    Vitamin D3 (as Cholecalciferol) 400 IU 100%
    Vitamin E (as DL-Alpha Tocopheryl Acetate) 15 IU 50%
    Thiamin (as Thiamine HCl, Vitamin B1) 1.2 mg 80%
    Riboflavin (Vitamin B2) 1.3 mg 76%
    Niacin (as Niacinamide) 5 mg 25%
    Vitamin B6 (as Pyridoxine HCl) 1.5 mg 75%
    Folate (as 200 mcg Quatrefolic® ((6S-5-methyltetrahydrofolic acid, glucosamine salt, molar equivalent to 108 mcg of Folic Acid), and 100 mcg of folic acid) 208 mcg 52%
    Vitamin B12 (as Cyanocobalamin) 4 mcg 67%
    Magnesium (as Magnesium Oxide) 15 mg 4%
    Copper (as Cupric Sulfate) 1 mg 50%
    Fluoride (as Sodium Fluoride) 0.5 mg

    Other Ingredients: Citric acid, fumed silica, magnesium stearate, microcrystalline cellulose, natural grape flavor, silicon dioxide, stearic acid, sucralose, sucrose and xylitol.

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  • INDICATIONS AND USAGE

    Quflora™ Pediatric Chewable Tablets with 0.5 mg Fluoride is a prescription dietary fluoride supplement providing twelve essential vitamins and minerals.

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  • CONTRAINDICATIONS

    Quflora™ Pediatric Chewable Tablets with 0.5 mg Fluoride should not be used by patients with a known history of hypersensitivity to any of the listed ingredients.

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  • PRECAUTIONS

    General

    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. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed. Your healthcare practitioner can prescribe the correct dosage.

    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.

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  • ADVERSE REACTIONS

    Allergic rash and other idiosyncrasies have been rarely reported. Call your doctor for medical advice about side effects. You may report side effects or obtain product information 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. This product should be chewed and is not recommended for children under age 4.

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  • DOSAGE AND ADMINISTRATION

    One tablet daily or as prescribed by your healthcare practitioner. Each tablet contains 0.5 mg fluoride ion (F) from 1.1 mg sodium fluoride (NaF).

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  • DESCRIPTION

    Quflora™ Pediatric Chewable Tablets with 0.5 mg Fluoride is a yellow round tablet imprinted "104".

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  • HOW SUPPLIED

    Quflora™ Pediatric Chewable Tablets with 0.5 mg Fluoride available in child-resistant bottles of 30 (Product Code: 15370-104-30).

    Rx Only

    STORAGE

    Store at controlled room temperature 20° C to 25° C (68° F to 77° F), excursions permitted between 15° C and 30° C (59° F and 86° F). Protect from light, moisture and excessive heat.

    KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

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  • 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
    www.carwinpharma.com

    Made in Canada

    Rev. 4/16

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  • PRINCIPAL DISPLAY PANEL - 0.25 mg Tablet Bottle Label

    15370-103-30

    QUfLORA™
    PEDIATRIC
    Chewable Tablets

    Multivitamin with
    0.25 mg Fluoride

    Each chewable tablet contains:
    0.55 mg sodium fluoride, USP

    Rx Only • Grape Flavor

    30 Tablets

    carwin
    PHARMACEUTICAL ASSOCIATES

    PRINCIPAL DISPLAY PANEL - 0.25 mg Tablet Bottle Label
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  • PRINCIPAL DISPLAY PANEL - 0.5 mg Tablet Bottle Label

    15370-104-30

    QUfLORA™
    PEDIATRIC
    Chewable Tablets

    Multivitamin with
    0.5 mg Fluoride

    Each chewable tablet contains:
    1.1 mg sodium fluoride, USP

    Rx Only • Grape Flavor

    30 Tablets

    carwin
    PHARMACEUTICAL ASSOCIATES

    PRINCIPAL DISPLAY PANEL - 0.5 mg Tablet Bottle Label
    Close
  • PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label

    15370-105-30

    QUfLORA™
    PEDIATRIC
    Chewable Tablets

    Multivitamin with
    1 mg Fluoride

    Each chewable tablet contains:
    2.2 mg sodium fluoride, USP

    Rx Only • Grape Flavor

    30 Tablets

    carwin
    PHARMACEUTICAL ASSOCIATES

    PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label
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  • INGREDIENTS AND APPEARANCE
    QUFLORA PEDIATRIC 
    vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, levomefolic acid, folic acid, cyanocobalamin, magnesium oxide, cupric sulfate, and sodium fluoride tablet, chewable
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15370-103
    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 1200 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 60 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU]
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 15 [iU]
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.2 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.3 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 5 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 1.5 mg
    LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID 108 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 100 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 4 ug
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 15 mg
    CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 1 mg
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.25 mg
    Inactive Ingredients
    Ingredient Name Strength
    GRAPE (UNII: 6X543N684K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 12mm
    Flavor GRAPE Imprint Code 103
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:15370-103-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/06/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 01/06/2014
    QUFLORA PEDIATRIC 
    vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, levomefolic acid, folic acid, cyanocobalamin, magnesium oxide, cupric sulfate, and sodium fluoride tablet, chewable
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15370-104
    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 1200 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 60 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU]
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 15 [iU]
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.2 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.3 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 5 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 1.5 mg
    LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID 108 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 100 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 4 ug
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 15 mg
    CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 1 mg
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    GRAPE (UNII: 6X543N684K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 12mm
    Flavor GRAPE Imprint Code 104
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:15370-104-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/06/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 01/06/2014
    QUFLORA PEDIATRIC 
    vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, levomefolic acid, folic acid, cyanocobalamin, magnesium oxide, cupric sulfate, and sodium fluoride tablet, chewable
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15370-105
    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 1200 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 60 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU]
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 15 [iU]
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.2 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.3 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 5 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 1.5 mg
    LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID 108 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 100 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 4 ug
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 15 mg
    CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 1 mg
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1 mg
    Inactive Ingredients
    Ingredient Name Strength
    GRAPE (UNII: 6X543N684K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 12mm
    Flavor GRAPE Imprint Code 105
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:15370-105-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/06/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 01/06/2014
    Labeler - CarWin Pharmaceutical Associates, LLC (079217215)
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