Quflora Pediatric Drops

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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
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	*	*

* Daily Value (DV) not established

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

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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
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

* 1.0 part per million (ppm) = 1 milligram/liter (mg/L)

† 2.2 mg sodium fluoride contains 1 mg fluoride ion

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

DESCRIPTION

DESCRIPTION SECTION

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

HOW SUPPLIED

HOW SUPPLIED SECTION

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

STORAGE AND HANDLING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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^®

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• 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
• VITAMIN A ACETATE
• VITAMIN A
• ASCORBIC ACID
• CHOLECALCIFEROL
• .ALPHA.-TOCOPHEROL ACETATE, D-
• .ALPHA.-TOCOPHEROL, D-
• THIAMINE HYDROCHLORIDE
• THIAMINE ION
• THIAMINE
• RIBOFLAVIN
• NIACINAMIDE
• PYRIDOXINE HYDROCHLORIDE
• PYRIDOXINE
• LEVOMEFOLIC ACID
• CYANOCOBALAMIN
• MAGNESIUM OXIDE
• MAGNESIUM CATION
• CUPRIC SULFATE
• CUPRIC CATION
• SODIUM FLUORIDE
• FLUORIDE ION
• CARRAGEENAN
• CITRIC ACID MONOHYDRATE
• GRAPE
• POTASSIUM SORBATE
• SUCRALOSE
• WATER

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