QUFLORA PEDIATRIC- vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, levomefolic acid, folic acid, cyanocobalamin, magnesium oxide, cupric sulfate and sodium fluoride tablet, chewable
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.
Nutrition FactsServing Size: 1 Chewable Tablet
Amount Per Tablet % DV for Adults and Children 4 or more years of age
*
Daily Value (DV) not established
Vitamin A (as Acetate) 1,200 IU 24%
Vitamin C (as Ascorbic Acid) 60 mg 100%
Vitamin D3 (as Cholecalciferol) 400 IU 100%
Vitamin E (as DL-Alpha-Tocopheryl Acetate) 15 IU 50%
Thiamin (as Thiamine HCl, Vitamin B1) 1.2 mg 80%
Riboflavin (Vitamin B2) 1.3 mg 76%
Niacin (as Niacinamide) 5 mg 25%
Vitamin B6 (as Pyridoxine HCl) 1.5 mg 75%
Folate (as 200 mcg Quatrefolic� ((6S-5-methyltetrahydrofolic acid, glucosamine salt *, molar equivalent to 108 mcg of Folic Acid), and 100 mcg of folic acid) 208 mcg 52%
Vitamin B12 (as Cyanocobalamin) 4 mcg 67%
Magnesium (as Magnesium Oxide) 15 mg 4%
Copper (as Cupric Sulfate) 1 mg 50%
Fluoride (as Sodium Fluoride) 0.5 mg *
Active Ingredient for caries prophylaxis: Fluoride as Sodium Fluoride (NaF).
Other Ingredients:
Artificial grape flavor, citric acid, fumed silica, magnesium stearate, microcrystalline cellulose, silicon dioxide, sucralose, sucrose, and stearic acid.
DESCRIPTION
Quflora� Pediatric Chewable Tablets are for use as a dental caries preventative in children.
Each Quflora� 1.0 mg F 1 (full strength) pediatric chewable tablet contains 2.2 mg sodium fluoride USP (equivalent to 1.0 mg Fluoride ion);
Each Quflora� 0.5 mg F 1 (half-strength) pediatric chewable tablet contains 1.1 mg sodium fluoride USP (equivalent to 0.5 mg Fluoride ion);
Each Quflora� 0.25 mg F 1 (quarter strength) pediatric chewable tablet contains 0.55 mg sodium fluoride (equivalent to 0.25 mg Fluoride ion).
1
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
CLINICAL PHARMACOLOGY
It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries.
Quflora� Pediatric Chewable Tablets provide sodium fluoride and twelve essential vitamins and minerals in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride.
