INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Quflora(TM) Pediatric Chewable Tablets with 0.5 mg Fluoride is prescription dietary fluoride supplement providing twelve essential vitamins and minerals.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 0.25 mg Tablet Bottle Label. 15370-103-30QUfLORA(TM) PEDIATRICChewable Tablets Multivitamin with0.25 mg FluorideEach chewable tablet contains: 0.55 mg sodium fluoride, USP Rx Only Grape Flavor30 TabletscarwinPHARMACEUTICAL ASSOCIATES PRINCIPAL DISPLAY PANEL 0.25 mg Tablet Bottle Label.

PRECAUTIONS SECTION.

PRECAUTIONS. General. 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. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed. Your healthcare practitioner can prescribe the correct dosage.. 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.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. One tablet daily or as prescribed by your healthcare practitioner. Each tablet contains 0.5 mg fluoride ion (F) from 1.1 mg sodium fluoride (NaF).

GENERAL PRECAUTIONS SECTION.

General. 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. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed. Your healthcare practitioner can prescribe the correct dosage.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Quflora(TM) Pediatric Chewable Tablets with 0.5 mg Fluoride available in child-resistant bottles of 30 (Product Code: 15370-104-30).Rx Only. STORAGE. Store at controlled room temperature 20 to 25 (68 to 77 F), excursions permitted between 15 and 30 (59 and 86 F). Protect from light, moisture and excessive heat.KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Allergic rash and other idiosyncrasies have been rarely reported. Call your doctor for medical advice about side effects. You may report side effects or obtain product information by calling Carwin Pharmaceutical Associates, LLC at 1-844-700-5011.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Quflora(TM) Pediatric Chewable Tablets with 0.5 mg Fluoride should not be used by patients with known history of hypersensitivity to any of the listed ingredients.

DESCRIPTION SECTION.

DESCRIPTION. Quflora(TM) Pediatric Chewable Tablets with 0.5 mg Fluoride is yellow round tablet imprinted 104.

SPL UNCLASSIFIED SECTION.

Supplement FactsServing Size: TabletServings per Container: 30Amountper Serving% DailyValue%Daily Value for Adults and Children or more years of age Vitamin (as Acetate)1,200 IU24%Vitamin (as Ascorbic Acid)60 mg100%Vitamin D3 (as Cholecalciferol)400 IU100%Vitamin (as DL-Alpha Tocopheryl Acetate)15 IU50%Thiamin (as Thiamine HCl, Vitamin B1)1.2 mg80%Riboflavin (Vitamin B2)1.3 mg76%Niacin (as Niacinamide)5 mg25%Vitamin B6 (as Pyridoxine HCl)1.5 mg75%Folate (as 200 mcg Quatrefolic(R) ((6S-5-methyltetrahydrofolic acid, glucosamine salt, molar equivalent to 108 mcg of Folic Acid), and 100 mcg of folic acid)208 mcg52%Vitamin B12 (as Cyanocobalamin)4 mcg67%Magnesium (as Magnesium Oxide)15 mg4%Copper (as Cupric Sulfate)1 mg50%Fluoride (as Sodium Fluoride)0.5 mgDaily Value not established. Other Ingredients: Citric acid, fumed silica, magnesium stearate, microcrystalline cellulose, natural grape flavor, silicon dioxide, stearic acid, sucralose, sucrose and xylitol.

STORAGE AND HANDLING SECTION.

STORAGE. Store at controlled room temperature 20 to 25 (68 to 77 F), excursions permitted between 15 and 30 (59 and 86 F). Protect from light, moisture and excessive heat.KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

WARNINGS SECTION.

WARNINGS. Keep out of the reach of children. In case of accidental overdose, seek professional emergency assistance or contact Poison Control Center immediately. This product should be chewed and is not recommended for children under age 4.