BOXED WARNING SECTION.

WARNING. Accidental overdose of iron-containing products is leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call doctor or poison control center immediately.

CONTRAINDICATIONS SECTION.

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 SECTION.

Supplement FactsServing Size: mL (Mark on dropper)Servings per Container: 50Amount Per mL% DV Children months to under years of age% DV for Adults and Children or more years of ageVitamin (as Palmitate)1500 IU60%30%Vitamin (as Ascorbic Acid)36 mg90%60%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)4 mg45%20%Pantothenic Acid1 mg20%10%Vitamin B6 (as Pyridoxine HCl)0.4 mg57%20%Biotin3 mcg2%1%Folate (as 69 mcg Quatrefolic(R) ((6S)-5 Methyltetrahydrofolic acid, glucosamine salt, molar equivalent to 37.5 mcg of Folic Acid))37.5 mcg20%10%Vitamin B12 (as Cyanocobalamin)2 mcg67%33%Iron (as Ferrous Sulfate)9.5 mg95%53%Fluoride (as Sodium Fluoride)0.25 mgDaily Value not establishedOther Ingredients: Purified Water, Citric Acid, Glycerin, Grape Flavor, Sorbitol, Propylene Glycol, Sucralose, Sodium Benzoate.

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. Each dropper full 1mL contains: 0.55 mg sodium fluoride, USP.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) FE Pediatric Liquid Drops in 50 mL (1 2/3 fl. oz.) child-resistant bottle with accompanying calibrated dropper. (Product Code: 15370-102-50).Rx Only. STORAGE. Store in cool, dry place at room temperature 20C to 25C (68F to 77F) away from heat and sunlight.SHAKE WELL BEFORE USING.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Quflora(R) FE Pediatric Liquid Drops is prescription dietary supplement providing essential vitamins, iron and fluoride.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 50 mL Bottle Carton. 15370-102-50QUfLORA(R) FEPEDIATRICLiquid Drops Dietary Supplement withIron 0.25 mg/mL FluorideRx Only Grape Flavor50 mL(1 2/3 fl oz.)carwinPHARMACEUTICAL ASSOCIATESQuatrefolic(R) PRINCIPAL DISPLAY PANEL 50 mL Bottle Carton.

PRECAUTIONS SECTION.

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.. WARNING. Accidental overdose of iron-containing products is leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call doctor or poison control center immediately.. Other information. Call your doctor for medical advice about side effects. You may report serious side effects or obtain product information by calling Carwin Pharmaceutical Associates, LLC at 1-844-700-5011.

SPL UNCLASSIFIED SECTION.

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.

STORAGE AND HANDLING SECTION.

STORAGE. Store in cool, dry place at room temperature 20C to 25C (68F to 77F) away from heat and sunlight.SHAKE WELL BEFORE USING.