Quflora Pediatric
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
Quflora™ Pediatric Chewable Tablets are for use as a dental caries preventative in children.
Each Quflora™ 1.0 mg F1 (full strength) pediatric chewable tablet contains 2.2 mg sodium fluoride USP (equivalent to 1.0 mg Fluoride ion);
Each Quflora™ 0.5 mg F1 (half-strength) pediatric chewable tablet contains 1.1 mg sodium fluoride USP (equivalent to 0.5 mg Fluoride ion);
Each Quflora™ 0.25 mg F1 (quarter strength) pediatric chewable tablet contains 0.55 mg sodium fluoride (equivalent to 0.25 mg Fluoride ion).
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- 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
Sources
Quflora Pediatric Manufacturers
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Carwin Pharmaceutical Associates, Llc
![Quflora Pediatric (Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolic Acid, Folic Acid, Cyanocobalamin, Magnesium Oxide, Cupric Sulfate, And Sodium Fluoride) Tablet, Chewable [Carwin Pharmaceutical Associates, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Quflora Pediatric | Carwin Pharmaceutical Associates, Llc
Dissolve in the mouth or chew before swallowing once daily, preferably at bedtime after brushing teeth. See schedule below to determine dosage.
Fluoride Ion Level In Drinking Water (ppm)* Age Less than 0.3ppm 0.3-0.6 ppm Greater than 0.6 ppm * 0.1 part per million (ppm) = 1 milligram/liter (mg/L) † 2.2 mg sodium fluoride contains 1 mg fluoride ion Birth-6 months None None None 6 months-3 years 0.25 mg/day† 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 NoneDosing schedule approved by the American Dental Association, American Academy of Pediatrics, American Academy of Pediatric Dentistry
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