QUFLORA GUMMIES- vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, pyridoxine hydrochloride, folic acid, cyanocobalamin, and sodium fluoride tablet, chewable 
Carwin Pharmaceutical Associates, LLC

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Quflora® Gummies

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.

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.

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
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 SUPPLEMENT09/25/201705/16/2023
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)

Revised: 5/2023
 
Carwin Pharmaceutical Associates, LLC