PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL 50 mL Bottle Carton. 15370-100-50QUfLORA(TM) PEDIATRICLiquid Drops Dietary Supplement0.25 mg/mL FluorideEach dropperful (1 mL) contains: 0.55 mg sodium fluoride, USP Rx Only Grape Flavor50 mL(1 2/3 fl oz.)carwinPHARMACEUTICAL ASSOCIATESQuatrefolic(R) PRINCIPAL DISPLAY PANEL 50 mL Bottle Carton.
CONTRAINDICATIONS. Do not use in areas where drinking water exceeds 0.6 ppm F. Do not administer to pediatric patients less than months old.
DESCRIPTION. Quflora(R) 0.25 mg/mL Pediatric Drops is light brown, dye free, grape flavored liquid.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION. See schedule below to determine dosage. Administer orally as prescribed by healthcare practitioner. Use with calibrated dropper for measuring doses.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 ppmBirth-6 monthsNoneNoneNone6 months-3 years0.25 mg/day2.2 mg sodium fluoride contains mg fluoride ion NoneNone3-6 years0.50 mg/day 0.25 mg/dayNone6-16 years1.0 mg/day0.50 mg/dayNoneDietary Fluoride Supplement dosing schedule approved by the American Dental Association (ADA), American Academy of Pediatrics (AAP) American Academy of Pediatric Dentistry (AAPD).
GENERAL PRECAUTIONS SECTION.
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.
HOW SUPPLIED SECTION.
HOW SUPPLIED. Quflora(R) 0.25 mg/mL 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 20C to 25C (68F to 77F). Protect from light, moisture and heat.SHAKE BEFORE USINGTAMPER EVIDENT: Do not use if seal is broken or missing.
INDICATIONS & USAGE SECTION.
INDICATIONS AND USAGE. Quflora(R) 0.25 mg/mL Pediatric Drops is prescription dietary supplement providing essential vitamins, minerals and fluoride.
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.
SPL UNCLASSIFIED SECTION.
Supplement FactsServing Size: mLServings Per Container: 50Amount Per mL% Daily Value Children months to under years of age% Daily Value for Adults and Children or more years of ageVitamin (as Acetate)1,000 IU40%20%Vitamin (as Ascorbic Acid)35 mg88%58%Vitamin D3 (as Cholecalciferol)400 IU100%100%Vitamin (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)0.8 mg9%4%Vitamin B6 (as Pyridoxine HCl)0.4 mg57%20%Folate (as 65 mcg Quatrefolic(R) ((6S-5-methyltetrahydrofolic acid, glucosamine saltDaily Value (DV) not established, molar equivalent to 35 mcg of Folic Acid))35 mcg18%9%Vitamin B12 (as Cyanocobalamin)2 mcg67%33%Magnesium (as Magnesium Oxide)10 mg5%3%Copper (as Cupric Sulfate)1 mg100%50%Fluoride (as Sodium Fluoride)0.25 mgOther Ingredients: Purified Water, Carrageenan, Sorbitol, Propylene Glycol, Glycerin, Grape Flavor, Potassium Sorbate, Sodium Benzoate, Citric Acid and Sucralose.
STORAGE AND HANDLING SECTION.
STORAGE. Store at controlled room temperature 20C to 25C (68F to 77F). Protect from light, moisture and heat.SHAKE BEFORE USINGTAMPER EVIDENT: Do not use if seal is broken or missing.
WARNINGS. Keep out of the reach of children. In case of accidental overdose, seek professional emergency assistance or contact Poison Control Center immediately.