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Quflora Pediatric Drops

Generic Name: 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
Dosage Form: oral liquid

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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 for Quflora Pediatric Drops

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.

Quflora Pediatric Drops 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).

Quflora Pediatric Drops Description

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

How is Quflora Pediatric Drops 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.

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®

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 LABEL Item Code (Source) NDC:15370-100
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A ACETATE (VITAMIN A) VITAMIN A 1000 [iU]  in 1 mL
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 35 mg  in 1 mL
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]  in 1 mL
.ALPHA.-TOCOPHEROL ACETATE, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 5 [iU]  in 1 mL
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE 0.5 mg  in 1 mL
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 0.6 mg  in 1 mL
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 0.8 mg  in 1 mL
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 0.4 mg  in 1 mL
LEVOMEFOLIC ACID (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 35 ug  in 1 mL
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 2 ug  in 1 mL
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 10 mg  in 1 mL
CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION 1 mg  in 1 mL
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.25 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
CARRAGEENAN  
CITRIC ACID MONOHYDRATE  
GRAPE  
POTASSIUM SORBATE  
SUCRALOSE  
WATER  
Product Characteristics
Color BROWN Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:15370-100-50 1 BOTTLE, DROPPER in 1 CARTON
1 50 mL in 1 BOTTLE, DROPPER
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)
Revised: 08/2017
 
CarWin Pharmaceutical Associates, LLC
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