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Quflora fe Pediatric Drops

Generic Name: multi-vitamins and iron
Dosage Form: oral drops

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 (Mark on dropper)
Servings per Container: 50
Amount Per 1 mL % DV Children 6 months to under 4 years of age % DV for Adults and Children 4 or more years of age
*
Daily Value not established
Vitamin A (as Palmitate) 1500 IU 60% 30%
Vitamin C (as Ascorbic Acid) 36 mg 90% 60%
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) 4 mg 45% 20%
Pantothenic Acid 1 mg 20% 10%
Vitamin B6 (as Pyridoxine HCl) 0.4 mg 57% 20%
Biotin 3 mcg 2% 1%
Folate (as 69 mcg Quatrefolic® ((6S)-5 Methyltetrahydrofolic acid, glucosamine salt, molar equivalent to 37.5 mcg of Folic Acid)) 37.5 mcg 20% 10%
Vitamin B12 (as Cyanocobalamin) 2 mcg 67% 33%
Iron (as Ferrous Sulfate) 9.5 mg 95% 53%
Fluoride (as Sodium Fluoride) 0.25 mg * *

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

Indications and Usage for Quflora fe Pediatric Drops

Quflora® FE Pediatric Liquid Drops is a prescription dietary supplement providing essential vitamins, iron 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.

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

Other information

Call your doctor for medical advice about side effects. You may report serious side effects or obtain product information by calling Carwin Pharmaceutical Associates, LLC at 1-844-700-5011.

Quflora fe 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. Each dropper full 1mL contains: 0.55 mg sodium fluoride, USP.

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 fe Pediatric Drops Description

Quflora® FE Pediatric Liquid Drops is a yellow, dye free, grape flavored liquid.

How is Quflora fe Pediatric Drops Supplied

Quflora® FE Pediatric Liquid Drops in a 50 mL (1 ⅔ fl. oz.) child-resistant bottle with accompanying calibrated dropper. (Product Code: 15370-102-50).

Rx Only

STORAGE

Store in a cool, dry place at room temperature 20°C to 25°C (68°F to 77°F) away from heat and sunlight.

SHAKE WELL 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
www.carwinpharma.com

Rev. 3/17

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

15370-102-50

QUfLORA®
FE
PEDIATRIC
Liquid Drops

Dietary Supplement with
Iron & 0.25 mg/mL Fluoride

Rx Only • Grape Flavor

50 mL
(1⅔ fl oz.)

carwin
PHARMACEUTICAL ASSOCIATES

Quatrefolic®

Quflora fe Pediatric Drops 
vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine hydrochloride, riboflavin, niacinamide, pantothenic acid, pyridoxine hydrochloride, biotin, levomefolate glucosamine, cyanocobalamin, ferrous sulfate, and sodium fluoride liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:15370-102
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A PALMITATE (VITAMIN A and RETINOL) VITAMIN A 1500 [iU]  in 1 mL
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 36 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 4 mg  in 1 mL
PANTOTHENIC ACID (PANTOTHENIC ACID) PANTOTHENIC ACID 1 mg  in 1 mL
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 0.4 mg  in 1 mL
BIOTIN (BIOTIN) BIOTIN 3 ug  in 1 mL
LEVOMEFOLATE GLUCOSAMINE (LEVOMEFOLATE GLUCOSAMINE) LEVOMEFOLATE GLUCOSAMINE 37.5 ug  in 1 mL
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 2 ug  in 1 mL
FERROUS SULFATE (FERROUS CATION) FERROUS CATION 9.5 mg  in 1 mL
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.25 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
CITRIC ACID MONOHYDRATE  
GLYCERIN  
SORBITOL  
PROPYLENE  
SUCRALOSE  
SODIUM BENZOATE  
Product Characteristics
Color YELLOW Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:15370-102-50 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 04/21/2017
Labeler - Carwin Pharmaceutical Associates, LLC (079217215)
Revised: 04/2017
 
Carwin Pharmaceutical Associates, LLC
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