Quflora Pediatric Drops

Generic Name: vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, levomefolic acid, cyanocobalamin, magnesium oxide, cupric sulfate and sodium fluoride
Dosage Form: oral liquid

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Quflora™ 0.5 mg/mL F1 Pediatric Fluoride Drops

1
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
Nutrition Facts
Serving Size: 1.0 mL (Mark on Dropper)
Amount Per 1 mL % Daily Value Children 6 months to under 4 years of age % Daily Value for Adults and Children 4 or more years of age
*
Daily Value (DV) not established
Vitamin A (as Acetate) 1,100 IU 44% 22%
Vitamin C (as Ascorbic Acid) 45 mg 113% 75%
Vitamin D3 (as Cholecalciferol) 400 IU 100% 100%
Vitamin E (as D-Alpha-Tocopheryl Acetate) 12 IU 120% 40%
Thiamin (as Thiamine HCl, Vitamin B1) 1 mg 143% 67%
Riboflavin (Vitamin B2) 1 mg 125% 59%
Niacin (as Niacinamide) 2 mg 22% 10%
Vitamin B6 (as Pyridoxine HCl) 1 mg 143% 50%
Folate (as 150 mcg Quatrefolic™ ((6S)-5 methytetrahydrofolic glucosamine salt, molar equivalent to 81 mcg of Folic Acid)) 81 mcg 41% 20%
Vitamin B12 (as Cyanocobalamin) 3 mcg 100% 50%
Magnesium (as Magnesium Oxide) 12 mg 6% 3%
Copper (as Cupric Sulfate) 1 mg 100% 50%
Fluoride (as Sodium Fluoride) 0.5 mg * *

Active Ingredient for caries prophylaxis: Fluoride as Sodium Fluoride (NaF).

Other Ingredients: Carrageenen, citric acid, grape flavor (natural), potassium sorbate, sucralose, and water.

Quflora Pediatric Drops Description

Quflora™ 0.5 mg/mL F1 Pediatric Fluoride Drops provide sodium fluoride and twelve essential vitamins and minerals in a grape flavored liquid that can be dispensed with a one mL dropper. Quflora™ 0.5 mg/mL F1 Pediatric Fluoride Drops contains 0.5 mg fluoride ion (F) from 1.1 mg sodium fluoride (NaF) per mL.

Quflora Pediatric Drops - Clinical Pharmacology

It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries.

Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:

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Three stages of fluoride deposition in tooth enamel can be distinguished:

  1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.
  2. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.
  3. After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.

Indications and Usage for Quflora Pediatric Drops

Supplementation of the diet with twelve essential vitamins and minerals.

Supplementation of the diet with fluoride for caries prophylaxis.

Quflora™ 0.5 mg/mL F1 Pediatric Fluoride Drops 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.

The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a half dose (0.5 mL) of Quflora™ 0.5 mg/mL F1 Pediatric Fluoride Drops.

See DOSAGE AND ADMINISTRATION for complete dosing guidelines.

Children using Quflora™ 0.5 mg/mL F1 Pediatric Fluoride Drops regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.

Contraindications

Do not use Quflora™ 0.5 mg/mL F1 Pediatric Fluoride Drops in areas where the fluoride content of the drinking water exceeds 0.6 ppm F-. Chronic renal insufficiency and failure, arthralgia, gastrointestinal ulceration and osteomalacia are contraindications to fluoride therapy. Quflora™ 0.5 mg/mL F1 Pediatric Fluoride Drops are not indicated for use in adults.

Warnings

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

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

Precautions

General

Please refer to the CONTRAINDICATIONS, WARNINGS and OVERDOSAGE sections for overdosage concerns.

The suggested dose of Quflora™ 0.5 mg/mL F1 Pediatric Fluoride Drops should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

Before prescribing Quflora™ 0.5 mg/mL F1 Pediatric Fluoride Drops, read these important considerations when using the dosage schedule found in DOSAGE AND ADMINISTRATION.

  • If fluoride level is unknown, drinking water should be tested for fluoride content before supplements are prescribed. For testing of fluoride content, contact the local or state health department.
  • All sources of fluoride should be evaluated with a thorough fluoride history.
  • Patient exposure to multiple water sources can make proper prescribing complex. Make sure the child is not receiving significant amounts of fluoride from other medications and swallowed toothpaste.
  • Ingestion of higher than recommended levels of fluoride by children has been associated with an increase in mild dental fluorosis in developing, unerupted teeth.
  • Fluoride supplements require long-term compliance on a daily basis.

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.

Drug Interactions

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported for male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. This dose is at least 400 times greater than the recommended daily dose of Quflora™ 0.5 mg/mL F1 Pediatric Fluoride Drops. Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data is conflicting. Some studies report chromosome damage in rodents while other studies using similar protocols report negative results. Potential adverse reproductive effects of fluoride exposure in humans have not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower doses of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. This dose is approximately 200 times greater than the recommended daily dose of Quflora™ 0.5 mg/mL F1 Pediatric Fluoride Drops.

Adverse Reactions

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.

Overdosage

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 (1mL) of Quflora™ 0.5 mg/mL F1 Pediatric Fluoride Drops contains 0.5 mg of fluoride. The treatment of choice depends upon the age of the child and the water fluoride content. A 50mL bottle of 0.5 mg/mL drops contains 25 mg of fluoride. The total amount of sodium fluoride in a 50mL bottle of Quflora™ 0.5 mg/mL F1 Pediatric Fluoride Drops conforms with the recommendations of the American Dental Association for the maximum to be dispensed at one time for safety purposes.

Quflora Pediatric Drops Dosage and Administration

See schedule below to determine dosage.

Administer as prescribed by a healthcare professional, once daily preferably at bedtime after brushing teeth.

May be dropped directly into mouth with dropper; or mixed with cereal, fruit juice or other food.

Fluoride Ion Level In Drinking Water (ppm)*
Age Less than 0.3ppm 0.3-0.6 ppm Greater than 0.6 ppm
*
1.0 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 None

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

How is Quflora Pediatric Drops Supplied

Quflora™ 0.5 mg/mL F1 Pediatric Fluoride Drops are available as a light brown, dye free, grape flavored liquid in 50 mL (1 2/3 FL. OZ.) bottles with accompanying calibrated dropper. (Product Code 15370-101-50).

STORAGE

Store at Controlled Room Temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

KEEP OUT OF REACH OF CHILDREN

Protect from light and moisture. Dispense in original container, since contact with glass leads to instability and precipitation.

TAMPER EVIDENT: Do not use if seal is broken or missing.

REFRIGERATION IS NOT REQUIRED.

Shake Well

Rx

Manufactured for:
CarWin Pharmaceutical Associates, LLC
Slidell, LA 70461

Manufactured in Canada

CAR-101-01
Rev. 06/14

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

15370-101-50

QUfLORA™
PEDIATRIC
Liquid Drops

0.5 mg/mL Fluoride

Each dropperful (1 mL) contains:
1.1 mg sodium fluoride, USP

Rx • Grape Flavor

50 mL
(1⅔ fl oz.)

CARWIN
PHARMACEUTICAL
ASSOCIATES, LLC

Quatrefolic®

Quflora Pediatric Drops 
vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, levomefolic acid, cyanocobalamin, magnesium oxide, cupric sulfate, and sodium fluoride liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:15370-101
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A ACETATE (VITAMIN A) VITAMIN A 1100 [iU]  in 1 mL
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 45 mg  in 1 mL
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]  in 1 mL
.ALPHA.-TOCOPHEROL ACETATE, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 12 [iU]  in 1 mL
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE 1 mg  in 1 mL
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1 mg  in 1 mL
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 2 mg  in 1 mL
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 1 mg  in 1 mL
LEVOMEFOLIC ACID (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 81 ug  in 1 mL
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 3 ug  in 1 mL
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 12 mg  in 1 mL
CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION 1 mg  in 1 mL
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
CARRAGEENAN  
CITRIC ACID MONOHYDRATE  
GRAPE  
POTASSIUM SORBATE  
SUCRALOSE  
WATER  
Product Characteristics
Color BROWN Score     
Shape Size
Flavor GRAPE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:15370-101-50 1 BOTTLE, DROPPER in 1 CARTON
1 50 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 07/15/2014
Labeler - CarWin Pharmaceutical Associates, LLC (079217215)
Revised: 07/2014
 
CarWin Pharmaceutical Associates, LLC
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