Quflora FE Pediatric Drops

Label at a glance#

Contacts and useful links#

PhoneLabel contact1-844-700-5011

Websitewww.carwinpharma.comwww.carwinpharma.com

Label contents#

Full prescribing information#

DESCRIPTION SECTION

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
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	*	*

* Daily Value not established

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

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

WARNING

BOXED WARNING SECTION

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

SPL UNCLASSIFIED SECTION

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.

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

HOW SUPPLIED

HOW SUPPLIED SECTION

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

STORAGE AND HANDLING SECTION

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

SPL UNCLASSIFIED SECTION

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
www.carwinpharma.com

Rev. 3/17

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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^®

DailyMed Pharmacologic Classes#

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FDA-Initiated Inactive NDC Indexing#

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

• 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
• VITAMIN A PALMITATE
• VITAMIN A
• RETINOL
• ASCORBIC ACID
• CHOLECALCIFEROL
• .ALPHA.-TOCOPHEROL ACETATE, D-
• .ALPHA.-TOCOPHEROL, D-
• THIAMINE HYDROCHLORIDE
• THIAMINE ION
• THIAMINE
• RIBOFLAVIN
• NIACINAMIDE
• PANTOTHENIC ACID
• PYRIDOXINE HYDROCHLORIDE
• PYRIDOXINE
• BIOTIN
• LEVOMEFOLATE GLUCOSAMINE
• CYANOCOBALAMIN
• FERROUS SULFATE
• FERROUS CATION
• SODIUM FLUORIDE
• FLUORIDE ION
• WATER
• CITRIC ACID MONOHYDRATE
• GLYCERIN
• SORBITOL
• PROPYLENE
• SUCRALOSE
• SODIUM BENZOATE

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 21 matching rows.

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