Quflora Fe Pediatric Drops
FDA Label NDC 15370-102

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Carwin Pharmaceutical Associates, Llc for the product Quflora Fe Pediatric Drops (NDC 15370-102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, indications and usage, contraindications, general, folic acid, warning, other information, dosage and administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Description

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 IU60%30%
Vitamin C (as Ascorbic Acid)36 mg90%60%
Vitamin D3 (as Cholecalciferol)400 IU100%100%
Vitamin E (as D-Alpha-Tocopheryl Acetate)5 IU50%17%
Thiamin (as Thiamine HCl, Vitamin B1)0.5 mg71%33%
Riboflavin (Vitamin B2)0.6 mg75%35%
Niacin (as Niacinamide)4 mg45%20%
Pantothenic Acid1 mg20%10%
Vitamin B6 (as Pyridoxine HCl)0.4 mg57%20%
Biotin3 mcg2%1%
Folate (as 69 mcg Quatrefolic® ((6S)-5 Methyltetrahydrofolic acid, glucosamine salt, molar equivalent to 37.5 mcg of Folic Acid))37.5 mcg20%10%
Vitamin B12 (as Cyanocobalamin)2 mcg67%33%
Iron (as Ferrous Sulfate)9.5 mg95%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.

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

Indications And Usage

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.

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.

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)

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

AgeLess than 0.3ppm0.3-0.6 ppmGreater than 0.6 ppm
Birth-6 monthsNoneNoneNone
6 months-3 years0.25 mg/day

2.2 mg sodium fluoride contains 1 mg fluoride ion

NoneNone
3-6 years0.50 mg/day0.25 mg/dayNone
6-16 years1.0 mg/day0.50 mg/dayNone

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

How 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.

Other

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®

Principal Display Panel (50 mL Bottle Carton)

Principal Display Panel (50 mL Bottle Carton)

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