HOW SUPPLIED SECTION.


HOW SUPPLIED Quflora FE Pediatric Liquid Drops in a 50 mL (1 fl. oz.) child-resistant bottle with accompanying calibrated dropper. (Product Code: 15370-102-50). Rx Only STORAGE Store in a cool, dry place at room temperature 20C to 25C (68F to 77F) away from heat and sunlight. SHAKE WELL BEFORE USING

SPL UNCLASSIFIED SECTION.


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 www.carwinpharma.com Rev. 3/17

DESCRIPTION SECTION.


DESCRIPTION Quflora FE Pediatric Liquid Drops is a yellow, dye free, grape flavored liquid.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton 15370-102-50 QUfLORA FE PEDIATRIC Liquid Drops Dietary Supplement with Iron & 0.25 mg/mL Fluoride Rx Only Grape Flavor 50 mL (1 fl oz.) carwin PHARMACEUTICAL ASSOCIATES Quatrefolic

INDICATIONS & USAGE SECTION.


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

DOSAGE & ADMINISTRATION SECTION.


DOSAGE AND ADMINISTRATION See schedule below to determine dosage. Administer orally as prescribed by a 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) Age Less than 0.3 ppm 0.3-0.6 ppm Greater than 0.6 ppm Birth-6 months None None None 6 months-3 years 0.25 mg/day2.2 mg sodium fluoride contains 1 mg fluoride ion 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).

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 a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a 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.

CONTRAINDICATIONS SECTION.


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.