Quflora fe Pediatric Drops

Name: Quflora fe Pediatric Drops

Indications and Usage for Quflora fe Pediatric Drops

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

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.

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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