FDA Label for Quflora Pediatric Drops
View Indications, Usage & Precautions
Quflora 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.
Other
| Supplement Facts Serving Size: 1 mL Servings Per Container: 50 | |||
|---|---|---|---|
| Amount Per 1 mL | % Daily Value Children 6 months to under 4 years of age | % Daily Value for Adults and Children 4 or more years of age | |
| Vitamin A (as Acetate) | 1,000 IU | 40% | 20% |
| Vitamin C (as Ascorbic Acid) | 35 mg | 88% | 58% |
| 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) | 0.8 mg | 9% | 4% |
| Vitamin B6 (as Pyridoxine HCl) | 0.4 mg | 57% | 20% |
| Folate (as 65 mcg Quatrefolic® ((6S-5-methyltetrahydrofolic acid, glucosamine salt Daily Value (DV) not established , molar equivalent to 35 mcg of Folic Acid)) | 35 mcg | 18% | 9% |
| Vitamin B12 (as Cyanocobalamin) | 2 mcg | 67% | 33% |
| Magnesium (as Magnesium Oxide) | 10 mg | 5% | 3% |
| Copper (as Cupric Sulfate) | 1 mg | 100% | 50% |
| Fluoride (as Sodium Fluoride) | 0.25 mg | ||
Other Ingredients: Purified Water, Carrageenan, Sorbitol, Propylene Glycol, Glycerin, Grape Flavor, Potassium Sorbate, Sodium Benzoate, Citric Acid and Sucralose.
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
CAR-100-02
Rev. 5/17
Indications And Usage
Quflora® 0.25 mg/mL F* Pediatric Drops is a prescription dietary supplement providing essential vitamins, minerals 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.
Other Information
Call your doctor for medical advice about side effects. You may report serious side effects by calling Carwin Pharmaceutical Associates, LLC at 1-844-700-5011.
Warnings
Keep out of the reach of children. In case of accidental overdose, seek professional emergency assistance or contact a Poison Control Center immediately.
Dosage And Administration
See schedule below to determine dosage. Administer orally as prescribed by a healthcare practitioner. Use with calibrated dropper for measuring doses.
| 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).
Description
Quflora® 0.25 mg/mL F* Pediatric Drops is a light brown, dye free, grape flavored liquid.
How Supplied
Quflora® 0.25 mg/mL F* Pediatric Drops in 50 mL (1 2/3 FL. OZ.) child-resistant bottles with accompanying calibrated dropper (Product Code: 15370-100-50).
Rx Only
Storage
Store at controlled room temperature 20°C to 25°C (68°F to 77°F). Protect from light, moisture and heat.
SHAKE BEFORE USING
TAMPER EVIDENT: Do not use if seal is broken or missing.
Principal Display Panel - 50 Ml Bottle Carton
15370-100-50
QUfLORA™
PEDIATRIC
Liquid Drops
Dietary Supplement
0.25 mg/mL Fluoride
Each dropperful (1 mL) contains:
0.55 mg sodium fluoride, USP
Rx Only • Grape Flavor
50 mL
(1⅔ fl oz.)
carwin
PHARMACEUTICAL ASSOCIATES
Quatrefolic®
* Please review the disclaimer below.