Tri-Vitamin Drops with Iron and Fluoride

Generic Name: vitamin a palmitate, ascorbic acid, cholecalciferol, ferrous sulfate and sodium fluoride
Dosage Form: oral drops

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.

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 LABEL Item Code (Source) NDC: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
# Item Code Package Description
1 NDC:50383-628-50 1 BOTTLE in 1 CARTON
1 50 mL in 1 BOTTLE
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(50383-628)
Revised: 01/2012
 
Hi-Tech Pharmacal Co., Inc.
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