FDA Label for Quflora Fe Pediatric Drops
View Indications, Usage & Precautions
Quflora Fe Pediatric Drops Product Label
The following document was submitted to the FDA by the labeler of this product Carwin Pharmaceutical Associates, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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 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.
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.
| 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 2.2 mg sodium fluoride contains 1 mg fluoride ion | 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).
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®
* Please review the disclaimer below.