Quflora Pediatric Chewable Tablets

Supplementation of the diet with twelve essential vitamins and minerals.

Supplementation of the diet with fluoride for caries prophylaxis.

See Dosage and Administration for complete dosing guidelines.

Quflora™ Pediatric Chewable Tablets supply significant amounts of Vitamins A, C, D, E, Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, along with Magnesium, and Copper to supplement the diet, and to help assure that nutritional deficiencies of these vitamins and minerals will not develop. Thus, in a single easy-to-use preparation, children obtain twelve essential vitamins and minerals, plus fluoride.

The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.

Children using Quflora™ Pediatric Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.

Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under 6 years of age, especially if the water fluoridation exceeds 0.6 ppm.

This product should be chewed and is not recommended for children under age 4 due to risk of choking.

Read directions carefully before using. Keep out of reach of infants and children.

Allergic rash and other idiosyncrasies have been rarely reported.

Call your doctor for medical advice about side effects. You may report adverse side effects or obtain product information by contacting CarWin Pharmaceutical Associates, LLC at 1-866-633-9033

Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) has been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) has been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.

A treatment dose of Quflora™ Pediatric Chewable Tablets contains 0.25, 0.5 or 1 mg of fluoride. The treatment of choice depends upon the age of the child and the water fluoride content. A bottle of 30 0.25 mg tablets contains 7.5 mg fluoride. A bottle of 30 0.5 mg tablets contains 15 mg fluoride. A bottle of 30 1 mg tablets contains 30 mg fluoride. The total amount of sodium fluoride in a bottle of 30 Quflora™ Pediatric Chewable Tablets (all strengths) conforms with the recommendations of the American Dental Association for the maximum to be dispensed at one time for safety purposes.

Dissolve in the mouth or chew before swallowing once daily, preferably at bedtime after brushing teeth. See schedule below to determine dosage.

Dosing schedule approved by the American Dental Association, American Academy of Pediatrics, American Academy of Pediatric Dentistry

NDC 15370-104-30

QUfLORA™
PEDIATRIC
Chewable Tablets

0.5 mg Fluoride
(half strength)

Each chewable tablet contains:
1.1 mg sodium fluoride, USP

Rx Only • Grape Flavor

30 Tablets

CARWIN
ASSOCIATES

Quatrefolic®