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

Quflora Gummies by

Drug Labeling and Warnings

Quflora Gummies by is a Other medication manufactured, distributed, or labeled by Carwin Pharmaceutical Associates, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.
Calories	9
Total Carbohydrates	3.8 g	*†
Sugars	0.19 g	*†
Vitamin A (as Palmitate)	1200 IU	24%
Vitamin C (as Ascorbic Acid)	60 mg	100%
Vitamin D3 (as Cholecalciferol)	600 IU	150%
Vitamin E (as d-alpha Tocopheryl Acetate)	15 IU	51%
Vitamin B6 (as Pyridoxine HCl)	1.5 mg	75%
Folic Acid	200 mcg	51%
Vitamin B12 (as Cyanocobalamin)	4 mcg	66%
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

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 Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:15370-210
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T, RETINOL - UNII:G2SH0XKK91)	VITAMIN A	1200 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	60 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	600 [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 HYDROCHLORIDE	1.5 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	200 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	4 ug
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.25 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:15370-210-60	60 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		09/25/2017

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	22 mm
flavor

Labeler - Carwin Pharmaceutical Associates, LLC (079217215)