Tri-Vit with Fluoride and Iron Drops

Dosage Form: oral solution
TRI-VIT WITH FLUORIDE 0.25 mg AND IRON DROPS


Rx only

Supplement Facts
Dosage Size 1 mL (Mark on Dropper)
Amount Per	% Daily Value
1 mL	Infants	Children Under
		Age 4 Years
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	*	*
*Daily Value (DV) not established

Active ingredient for caries prophylaxis:

Each 1 mL contains 0.25 mg fluoride as sodium fluoride.

Other ingredients:

ascorbic acid (Vitamin C), caramel color, cholecalciferol (Vitamin D3), ferrous sulfate, flavor, glycerin, polysorbate 80, purified water, 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. Three stages of fluoride deposition in tooth enamel can be distinguished:1 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.

INDICATIONS AND USAGE:

Supplementation of the diet with vitamins A, D, C, and iron. Supplementation of the diet with fluoride for caries prophylaxsis. TRI-VIT with FLUORIDE 0.25 mg and IRON (vitamins A, D, C, iron and fluoride) drops provide fluoride in drop form for infants and young children from 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 to 6 years in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride.2,3

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the 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 TRI-VIT with FLUORIDE 0.25 mg and IRON drops: 1) Determine the fluoride content of the drinking water from all major sources. 2) Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste. 3) Periodically check to make sure that the child does not develop significant dental fluorosis.

TRI-VIT with FLUORIDE 0.25 mg and IRON 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.

DOSAGE AND ADMINISTRATION:

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

DISPENSE in original container

Occasional deepening of color has no significant effect on vitamin potency.

While taking drops with iron, a slight darkening of the teeth may occur. Brushing will minimize this temporary condition.

After opening, store away from direct light.

Your doctor or dentist is the best source of counsel and guidance in your child’s fluoride supplementation.

REFERENCES

1. Brudevold F, McCann HG. Fluoride and caries control - Mechanism of action. In: Nizel AE, ed. The Science of Nutrition and Its Application in Clinical Dentistry. Philadelphia: WB Saunders Co.; 1966;331-347.


2. American Academy of Pediatrics, Committee on Nutrition: Fluoride Supplementation for Children: Interim Policy Recommendations. Pediatrics. 1995;95:777.


3. American Dental Association Council on Dental Therapeutics. New Fluoride Schedule Adopted. ADA News. May 16, 1994;12-14.

Manufactured for:

QUALITEST PHARMACEUTICALS

130 VINTAGE DRIVE

HUNTSVILLE, AL 35811

R4/09-R5

8277542

PRINCIPAL DISPLAY PANEL

 

PRINCIPAL DISPLAY PANEL

 

Tri-Vit with Fluoride and Iron Drops  vitamin a palmitate and ascorbic acid and cholecalciferol and ferrous sulfate and sodium fluoride solution  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0603-1787 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A PALMITATE (VITAMIN A) 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) FERROUS SULFATE 10 mg  in 1 mL SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 0.25 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN   POLYSORBATE 80   WATER   ANHYDROUS CITRIC ACID   SODIUM HYDROXIDE

Product Characteristics Color BROWN (clear and brown) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0603-1787-47 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC 1 50 mL In 1 BOTTLE, PLASTIC This package is contained within the CARTON (0603-1787-47)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		11/17/1997

Labeler - Qualitest Pharmaceuticals (011103059)

Establishment
Name	Address	ID/FEI	Operations
Vintage Pharmaceuticals-Huntsville		825839835	MANUFACTURE

Revised: 07/2011Qualitest Pharmaceuticals