Label: QUFLORA FE- vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, levomefolate glucosamine, cyanocobalamin, biotin, calcium pantothenate, iron pentacarbonyl, zinc oxide, copper, and sodium fluoride tablet, chewable

  • NHRIC Code(s): 15370-120-30
  • Packager: CarWin Pharmaceutical Associates, LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated July 15, 2016

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  • STATEMENT OF IDENTITY

    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)2500 IU50%
    Vitamin C (as Ascorbic Acid)100 mg167%
    Vitamin D3 ( as Cholecalciferol)600 IU150%
    Vitamin E (as DL-Alpha Tocopheryl Acetate)30 IU100%
    Thiamine (as Thiamine HCl)1.5 mg100%
    Riboflavin (Vitamin B2)1 mg59%
    Niacin (as Niacinamide)20 mg100%
    Vitamin B6 (as Pyridoxine HCl)2 mg100%
    Folate (as 400 mcg Quatrefolic® ((6S-5 methyltetrahydrofolic acid, glucosamine salt, molar equivalent 216 mcg of Folic Acid)216 mcg54%
    Vitamin B12 (as Cyanocobalamin)9 mcg150%
    Biotin45 mcg15%
    Pantothenic Acid (as D-Calcium Pantothenate)10 mg100%
    Iron (as Carbonyl iron)9 mg50%
    Zinc (as Zinc oxide)12 mg80%
    Copper (as Copper HVP chelate)1 mg50%
    Fluoride (as Sodium Fluoride)0.25 mg†

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

  • INDICATIONS AND USAGE

    Quflora™ FE Chewable Tablets Multivitamin with Iron and Fluoride 0.25mg is a prescription dietary fluoride supplement providing essential vitamins and minerals.

  • CONTRAINDICATIONS

    Quflora™ FE Chewable Tablets Multivitamin with Iron and Fluoride 0.25 mg should not be used by patients with a known history of hypersensitivity to any of the listed ingredients.

  • 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.

  • 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.

  • WARNINGS

    WARNING: 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, call a doctor or poison control center immediately.
  • DOSAGE AND ADMINISTRATION

    One tablet daily or as prescribed by your healthcare practitioner. This product should be chewed and is not recommended for children under age 4.

  • DESCRIPTION

    Quflora™ FE Chewable Tablets is a gray with yellowish tint, round tablet imprinted "120".

  • HOW SUPPLIED

    Quflora™ FE Chewable Tablets are available in child-resistant bottles of 30 (Product Code: 15370-120-30).

    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.

    THIS PRODUCT CONTAINS IRON.

  • SAFE HANDLING WARNING

    KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

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

    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

  • HEALTH CLAIM

    Manufactured for:
    Carwin Pharmaceutical Associates, LLC
    Hazlet, NJ 07730
    www.carwinpharma.com

    Made in Canada

    Rev. 5/16

  • PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label

    15370-120-30

    QUfLORA™ FE
    Chewable Tablets

    Multivitamin with
    Iron & Fluoride 0.25 mg

    Rx Only • Grape Flavor

    30 Tablets

    carwin
    PHARMACEUTICAL ASSOCIATES

    PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    QUFLORA FE 
    vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, levomefolate glucosamine, cyanocobalamin, biotin, calcium pantothenate, iron pentacarbonyl, zinc oxide, copper, and sodium fluoride tablet, chewable
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:15370-120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A2500 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL600 [iU]
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-30 [iU]
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE1.5 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE2 mg
    LEVOMEFOLATE GLUCOSAMINE (UNII: Q65PL71Q1A) (LEVOMEFOLATE GLUCOSAMINE - UNII:Q65PL71Q1A) LEVOMEFOLATE GLUCOSAMINE216 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN9 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN45 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737, CALCIUM CATION - UNII:2M83C4R6ZB) PANTOTHENIC ACID10 mg
    IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION9 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 mg
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER1 mg
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    GRAPE (UNII: 6X543N684K)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:15370-120-3030 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT07/12/2016
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)14 mm
    imprint
    flavor
    Labeler - CarWin Pharmaceutical Associates, LLC (079217215)
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