Quflora Pediatric Drops

QUFLORA PEDIATRIC DROPS- vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, levomefolic acid, cyanocobalamin, magnesium oxide, cupric sulfate and sodium fluoride liquid
CarWin Pharmaceutical Associates, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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
*
Daily Value (DV) not established
Vitamin A (as Acetate) 1,100 IU 44% 22%
Vitamin C (as Ascorbic Acid) 45 mg 113% 75%
Vitamin D3 (as Cholecalciferol) 400 IU 100% 100%
Vitamin E (as D-Alpha-Tocopheryl Acetate) 12 IU 120% 40%
Thiamin (as Thiamine HCl, Vitamin B1) 1 mg 143% 67%
Riboflavin (Vitamin B2) 1 mg 125% 59%
Niacin (as Niacinamide) 2 mg 22% 10%
Vitamin B6 (as Pyridoxine HCl) 1 mg 143% 50%
Folate (as 150 mcg Quatrefolic® ((6S)-5-methyltetrahydrofolic acid, glucosamine salt *, molar equivalent to 81 mcg of Folic Acid)) 81 mcg 41% 20%
Vitamin B12 (as Cyanocobalamin) 3 mcg 100% 50%
Magnesium (as Magnesium Oxide) 12 mg 6% 3%
Copper (as Cupric Sulfate) 1 mg 100% 50%
Fluoride (as Sodium Fluoride) 0.5 mg * *

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

Quflora Pediatric Drops Indications and Usage

Quflora® 0.5 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

PRECAUTIONS

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.

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).

DESCRIPTION

Quflora® 0.5 mg/mL F* Pediatric Drops is a light brown, dye free, grape flavored liquid.

HOW SUPPLIED

Quflora® 0.5 mg/mL F* Pediatric Drops in 50 mL (1 2/3 FL. OZ.) child-resistant bottles with accompanying calibrated dropper (Product Code: 15370-101-50).

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.

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-101-02
Rev. 5/17

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