Tri-Vitamin Drops with Iron and Fluoride

Dosage Form: oral drops
Tri-Vitamin Drops with iron & fluoride

Vitamins A, C, D, Iron and Fluoride Drops

0.25 mg per mL

Rx only

Tri-Vitamin Drops with Iron and Fluoride Description

* U.S. Recommended Daily Allowance has not been established.
		Percentage of U.S. Recommended Daily Allowance
Each 1.0 mL supplies:		Infants	Children Under 4
Vitamin A	1500 IU	100	60
Vitamin C	35 mg	100	88
Vitamin D	400 IU	100	100
Iron	10 mg	67	100
Fluoride	0.25 mg	*	*

Active Ingredient for carles prophylaxis: Each 1 mL contains 0.25 mg fluoride as sodium fluoride.

Other ingredients: Ascorbic acid, caramel color, cherry flavor, cholecalciferol, ferrous sulfate, glycerin, methylparaben, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium hydroxide, vitamin A palmitate.

Citric Acid may be used to adjust pH.

Tri-Vitamin Drops with Iron and Fluoride - 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:

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, supplementary fluoride and smaller amounts from saliva.

Indications and Usage for Tri-Vitamin Drops with Iron and Fluoride

Vitamins A, C, D, Iron and Fluoride Drops may be useful for infants and children whose diets are lacking in vitamins A, C, D and iron.

Vitamins A, C, D, Iron and Fluoride Drops also provide fluoride for caries prophylaxis.

Vitamins A, C, D, Iron and Fluoride Drops were developed to provide fluoride in drop form for infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride; and for children ages 3-6 years in areas where the drinking water containes 0.3 thru 0.6 ppm of fluoride. Each 1.0 mL supplies sodium fluoride (0.25 mg fluoride) plus three basic vitamins and iron.

Warnings

WARNINGS

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.

Precautions

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

When prescribing Vitamin A, C, D, Iron and Fluoride Drops:

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.

Vitamins A, C, D, Iron and Fluoride 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 Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010.

Tri-Vitamin Drops with Iron and Fluoride Dosage and Administration

1.0 mL daily, or as prescribed. May be dropped directly into mouth with dropper, or mixed with cereal, fruit juice or other food. USE FULL DOSAGE.

How is Tri-Vitamin Drops with Iron and Fluoride Supplied

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

RECOMMENDED STORAGE:

Store at room temperature, protect from light. Dispense in original container.

Manufactured By:

HI-TECH PHARMACAL CO., INC.

Amityville, NY 11701

Rev. 628:05 4/09

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 50383-628-50

Tri-Vitamin Drops with iron

0.25 mg

VITAMINS A, C, D IRON AND FLUORIDE

Rx Only

 

1 2/3 FL. OZ. (50 mL)

TRI-VITAMIN WITH IRON AND FLUORIDE  vitamins a, c, d, iron and fluoride  solution/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50383-628 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A PALMITATE (VITAMIN A PALMITATE) VITAMIN A PALMITATE 1500 [iU]  in 1 mL ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 35 mg  in 1 mL CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]  in 1 mL FERROUS SULFATE (IRON) IRON 10 mg  in 1 mL SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.25 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN   METHYLPARABEN   POLYSORBATE 80   PROPYLENE GLYCOL   WATER   SODIUM BENZOATE   SODIUM HYDROXIDE   ANHYDROUS CITRIC ACID

Product Characteristics Color      Score      Shape Size Flavor CHERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50383-628-50 1  In 1 CARTON contains a BOTTLE 1 50 mL In 1 BOTTLE This package is contained within the CARTON (50383-628-50)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		05/06/1997	03/24/2012

Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)

Establishment
Name	Address	ID/FEI	Operations
Hi-Tech Pharmacal Co., Inc.		101196749	MANUFACTURE

Revised: 01/2012Hi-Tech Pharmacal Co., Inc.