VITAMINS A, C, D and FLUORIDE

VITAMINS A, C, D AND FLUORIDE- vitamin a palmitate, ascorbic acid, cholecalciferol and sodium fluoride solution/ drops
Libertas Pharma, Inc.

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.

DESCRIPTION

*
U.S. RDA not established
Each 1.0 mL supplies: Percentage of U.S. Recommended Daily Allowance
Infants Children Under 4
Vitamin A 1500 IU 100 60
Vitamin C (Ascorbic Acid) 35 mg 100 88
Vitamin D 400 IU 100 100
Fluoride 0.25 mg * *

See INDICATIONS AND USAGE section below for use by infants and young children 6 months to 3 years of age.

Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.

Other Ingredients: Ascorbic acid, caramel color, cholecalciferol, citric acid, ferrous sulfate, flavor, glycerin, methylparaben, niacinamide, polysorbate 80, purified water, sodium benzoate, sodium hydroxide, sucralose, vitamin A palmitate.

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:

Reaction Equation

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 water, food, supplementary fluoride and smaller amounts from saliva.
Reaction Equation

INDICATIONS AND USAGE

Supplementation of the diet with Vitamins A, C, D and Fluoride 0.25 mg Drops also provides fluoride for caries prophylaxis.

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. Vitamins A, C, D and Fluoride 0.25 mg Drops provide fluoride in drop form for infants and young children 6 months to 3 years of age, in areas where the drinking water contains children ages 2-3 years where the drinking water contains less than 0.3 ppm of fluoride and for children over 3 years, in areas where the drinking water contains 0.3 through 0.7 ppm of fluoride. Each 1.0 mL provides sodium fluoride (0.25 mg fluoride) plus eight essential vitamins and iron.

The American Academy of Pediatrics recommends that infants and young children under 6 months to 3 years of age, in areas where drinking water contains less than 0.3 ppm of fluoride, and; and for children ages 3-6 years, 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 full dose (1mL) of Vitamins A, C, D and Fluoride.

Vitamins A, C, D and Fluoride 0.25 mg Drops provide significant amounts of vitamins A, D, E, C thiamine, riboflavin, niacin, pyridoxine, and iron to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain eight essential vitamins and iron, plus fluoride.

A comprehensive 5 1/2 year series of studies of the effectiveness of multivitamin, iron, and fluoride drops in caries protection has been published. Children in this continuing study lived in an area where the water supply contained only 0.05 ppm fluoride. The subjects were divided in to two groups, one which used only the non-fluoride vitamin product, and the other multi-vitamins and fluoride drop products.

The three year interim report showed 63% fewer carious surfaces in primary teeth and 43% fewer carious surfaces in permanent teeth of the children taking multi-vitamin-fluoride products.

Results at the end of the 5-1/2 years further confirmed the previous finds and indicated that significant reductions in dental caries are apparent with the continued use of multi-vitamin-fluoride products.

WARNINGS

As in the case of all medications, keep out of reach of children.

PRECAUTIONS

The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride. When prescribing vitamin fluoride products:

  1. Determine the fluoride content of the drinking water.
  2. Make sure the child is not receiving significant amounts of fluoride from other medications and swallowed toothpaste.
  3. Periodically check to make sure that the child does not develop significant dental fluorosis.
  4. Vitamins A, C, D and Fluoride 0.25 mg Drops should be dispensed in the original plastic container, since contact with glass leads to instability and precipitation. (The amount of sodium fluoride in the 50-mL size is well below the maximum to be dispensed at one time according to recommendations of the American Dental Association.)

ADVERSE REACTIONS

Allergic rash and other idiosyncrasies have been rarely reported.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

1.0 mL daily or as prescribed by physician. May be dropped directly into mouth with the enclosed dropper or mixed with cereal, fruit juice or other food.

HOW SUPPLIED

Vitamins A, C, D and Fluoride 0.25 mg Drops are available in 50 mL bottles with accompanying calibrated dropper, NDC 51862-164-50.

RECOMMENDED STORAGE:

Store at controlled room temperature, 20º-25ºC (68º-77ºF). [See USP Controlled Room Temperature]. After opening, store away from direct light. Close tightly after each use. REFRIGERATION IS NOT REQUIRED.

TAMPER EVIDENT: Do not use if printed bottle seal around bottle cap is broken or missing.

Manufactured for:
Libertas Pharma, Inc.
Lawrenceville, GA 30043

Iss. 03/11 164-50 743629

Container Label

NDC 51862-164-50

Rx Only

VITAMINS A, C, D

and FLUORIDE

0.25 mg Drops

1 2/3 fl. oz. (50 mL)

Libertas
Pharma Inc.

Container Label
(click image for full-size original)

VITAMINS A, C, D AND FLUORIDE
vitamins a, c, d and fluoride solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51862-164
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A PALMITATE (VITAMIN A) VITAMIN A 1500 [iU] in 1 mL
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 35 mg in 1 mL
CHOLECALCIFEROL (VITAMIN D) VITAMIN D 400 [iU] in 1 mL
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CARAMEL
CITRIC ACID MONOHYDRATE
FERROUS SULFATE
CHERRY
GLYCERIN
METHYLPARABEN
POLYSORBATE 80
WATER
SODIUM BENZOATE
SODIUM HYDROXIDE
SUCRALOSE
Product Characteristics
Color BROWN (brown to brownish green) Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51862-164-50 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
1 50 mL in 1 BOTTLE This package is contained within the CARTON (51862-164-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/21/2011
Labeler — Libertas Pharma, Inc. (962128943)

Revised: 05/2011 Libertas Pharma, Inc.

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