QUFLORA GUMMIES (VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, AND SODIUM FLUORIDE) TABLET, CHEWAB

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  • QUFLORA GUMMIES (VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, AND SODIUM FLUORIDE) TABLET, CHEWAB

QUFLORA GUMMIES (VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, AND SODIUM FLUORIDE) TABLET, CHEWAB
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NDC 15370-210-60
Set ID 331018fa-c5d5-43e7-b3d1-cae6753710ba
Category DIETARY SUPPLEMENT
Packager Carwin Pharmaceutical Associates, LLC
Generic Name
Product Class
Product Number
Application Number
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  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size: 2 Gummies
    Servings Per Container: 30
    Amount Per Serving:% Daily Value
    *
    Percent Daily Value not established.
    †
    Percent Daily Values based on 2,000 calorie diet.
    Calories9
    Total Carbohydrates3.8 g*†
      Sugars0.19 g*†
    Vitamin A (as Palmitate)1200 IU24%
    Vitamin C (as Ascorbic Acid)60 mg100%
    Vitamin D3 (as Cholecalciferol)600 IU150%
    Vitamin E (as d-alpha Tocopheryl Acetate)15 IU51%
    Vitamin B6 (as Pyridoxine HCl)1.5 mg75%
    Folic Acid200 mcg51%
    Vitamin B12 (as Cyanocobalamin)4 mcg66%
    Fluoride (as Sodium Fluoride)0.25 mg*

    Other Ingredients: fructooligosaccharides, xylitol, inulin, water, gelatin, lactic acid, citric acid, mannitol, natural orange flavor, natural color (Yellow-Curcumin E100 & Orange-Paprika extract E-160c), concentrate stevia.

  • INDICATIONS AND USAGE

    Quflora® Gummies is a dietary supplement indicated to provide essential vitamins and fluoride supplementation.

  • CONTRAINDICATIONS

    Quflora® Gummies 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

    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.

  • DOSAGE AND ADMINISTRATION

    Take two (2) gummies daily, or as directed by a healthcare practitioner. Chew thoroughly before swallowing.

  • HOW SUPPLIED

    Quflora® Gummies is available as an orange slice shaped gummy. Orange flavor. Available in a child-resistant bottle containing 60 gummies (15370-210-60) and in a professional sample (15370-210-02).

    Store in a cool, dry place, tightly closed. Room temperature 15°-25°C (59°-77°F). Protect from light, moisture and heat.

  • SAFE HANDLING WARNING

    Rx Only

    KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

    TAMPER EVIDENT: Do not use if seal is broken or missing. Natural colors may darken over time. This does not alter the potency of the product.

  • HEALTH CLAIM

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

    Made in Colombia

    Rev. 2/17

  • PRINCIPAL DISPLAY PANEL - 60 Gummy Bottle Label

    15370-210-60

    QUfLORA®
    GUMMIES

    Dietary Supplement with 0.25 mg Fluoride

    Rx Only

    carwin
    PHARMACEUTICAL ASSOCIATES

    Orange Flavor
    60 Gummies

    Principal Display Panel - 60 Gummy Bottle Label
  • INGREDIENTS AND APPEARANCE
    QUFLORA GUMMIES 
    vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, pyridoxine hydrochloride, folic acid, cyanocobalamin, and sodium fluoride tablet, chewable
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:15370-210
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T, RETINOL - UNII:G2SH0XKK91) VITAMIN A1200 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL600 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-15 [iU]
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE1.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID200 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN4 ug
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    INULIN (UNII: JOS53KRJ01)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MANNITOL (UNII: 3OWL53L36A)  
    CURCUMIN (UNII: IT942ZTH98)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:15370-210-6060 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT09/25/2017
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)22 mm
    flavor
    Labeler - Carwin Pharmaceutical Associates, LLC (079217215)
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