QUFLORA PEDIATRIC DROPS- vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, levomefolic acid, cyanocobalamin, magnesium oxide, cupric sulfate, and sodium fluoride liquid

Quflora Pediatric Drops by

Drug Labeling and Warnings

Quflora Pediatric Drops by is a Prescription medication manufactured, distributed, or labeled by CarWin Pharmaceutical Associates, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Supplement Facts Serving Size: 1 mL Servings Per Container: 50
Amount Per 1 mL		% Daily Value Children 6 months to under 4 years of age	% Daily Value for Adults and Children 4 or more years of age
* Daily Value (DV) not established
Vitamin A (as Acetate)	1,000 IU	40%	20%
Vitamin C (as Ascorbic Acid)	35 mg	88%	58%
Vitamin D3 (as Cholecalciferol)	400 IU	100%	100%
Vitamin E (as D-Alpha-Tocopheryl Acetate)	5 IU	50%	17%
Thiamin (as Thiamine HCl, Vitamin B1)	0.5 mg	71%	33%
Riboflavin (Vitamin B2)	0.6 mg	75%	35%
Niacin (as Niacinamide)	0.8 mg	9%	4%
Vitamin B6 (as Pyridoxine HCl)	0.4 mg	57%	20%
Folate (as 65 mcg Quatrefolic® ((6S-5-methyltetrahydrofolic acid, glucosamine salt*, molar equivalent to 35 mcg of Folic Acid))	35 mcg	18%	9%
Vitamin B12 (as Cyanocobalamin)	2 mcg	67%	33%
Magnesium (as Magnesium Oxide)	10 mg	5%	3%
Copper (as Cupric Sulfate)	1 mg	100%	50%
Fluoride (as Sodium Fluoride)	0.25 mg	*	*

Other Ingredients: Purified Water, Carrageenan, Sorbitol, Propylene Glycol, Glycerin, Grape Flavor, Potassium Sorbate, Sodium Benzoate, Citric Acid and Sucralose.

INDICATIONS AND USAGE

Quflora® 0.25 mg/mL F* Pediatric Drops is a prescription dietary supplement providing essential vitamins, minerals and fluoride.

CONTRAINDICATIONS

Do not use in areas where drinking water exceeds 0.6 ppm F. Do not administer to pediatric patients less than 6 months old.

PRECAUTIONS

General

Do not use this product if you are allergic to any of the ingredients. 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 since these may decrease effectiveness.

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.

Other information

Call your doctor for medical advice about side effects. You may report serious side effects 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.

DOSAGE AND ADMINISTRATION

See schedule below to determine dosage. Administer orally as prescribed by a healthcare practitioner. Use with calibrated dropper for measuring doses.

Fluoride Ion Level In Drinking Water (ppm)*

Age	Less than 0.3ppm	0.3-0.6 ppm	Greater than 0.6 ppm
* 1.0 part per million (ppm) = 1 milligram/liter (mg/L) † 2.2 mg sodium fluoride contains 1 mg fluoride ion
Birth-6 months	None	None	None
6 months-3 years	0.25 mg/day†	None	None
3-6 years	0.50 mg/day†	0.25 mg/day	None
6-16 years	1.0 mg/day	0.50 mg/day	None

Dietary Fluoride Supplement dosing schedule approved by the American Dental Association (ADA), American Academy of Pediatrics (AAP) & American Academy of Pediatric Dentistry (AAPD).

DESCRIPTION

Quflora® 0.25 mg/mL F* Pediatric Drops is a light brown, dye free, grape flavored liquid.

HOW SUPPLIED

Quflora® 0.25 mg/mL F* Pediatric Drops in 50 mL (1 2/3 FL. OZ.) child-resistant bottles with accompanying calibrated dropper (Product Code: 15370-100-50).

Rx Only

STORAGE

Store at controlled room temperature 20°C to 25°C (68°F to 77°F). Protect from light, moisture and heat.

SHAKE BEFORE USING

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

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

CAR-100-02
Rev. 5/17

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

15370-100-50

QUfLORA™
PEDIATRIC
Liquid Drops

Dietary Supplement
0.25 mg/mL Fluoride

Each dropperful (1 mL) contains:
0.55 mg sodium fluoride, USP

Rx Only Grape Flavor

50 mL
(1⅔ fl oz.)

carwin
PHARMACEUTICAL ASSOCIATES

Quatrefolic®

INGREDIENTS AND APPEARANCE

QUFLORA PEDIATRIC DROPS 
vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, levomefolic acid, cyanocobalamin, magnesium oxide, cupric sulfate, and sodium fluoride liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 15370-100
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	1000 [iU]  in 1 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	35 mg  in 1 mL
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]  in 1 mL
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL, D-	5 [iU]  in 1 mL
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	0.5 mg  in 1 mL
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	0.6 mg  in 1 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.8 mg  in 1 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	0.4 mg  in 1 mL
LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLIC ACID	35 ug  in 1 mL
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	2 ug  in 1 mL
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM OXIDE	10 mg  in 1 mL
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	1 mg  in 1 mL
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARRAGEENAN (UNII: 5C69YCD2YJ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GRAPE (UNII: 6X543N684K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15370-100-50	1 in 1 CARTON	07/15/2014
1		50 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		07/15/2014

Labeler - CarWin Pharmaceutical Associates, LLC (079217215)