Multi Vitamin with Fluoride

Name: Multi Vitamin with Fluoride

Clinical pharmacology

Significant decrease in the incidence of dental caries can be linked to the fluoridation of the water supply (1ppm fluoride) during the period of tooth development.

Multi-Vitamin with Fluoride Chewable Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride.

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:

Ca10(PO4)6(OH)2 + 2F-  > Ca10(PO4)6F2 + 2OH-

(Hydroxyapatite)                                   (Fluorapatite)

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.

Warnings

AS IN THE CASE OF ALL MEDICATIONS, KEEP OUT OF THE REACH OF CHILDREN.

This tablet should be chewed. This product, as with all chewable tablets, are not recommended for children under age 4 due to risk of choking.

Dosage and administration

One tablet daily or as prescribed.

Container Label

NDC 51862-152-01

Rx Only

Multi-Vitamin

with Fluoride

Chewable Tablets

0.5 mg

Multi Vitamin and Fluoride Supplement

100 Tablets

Libertas
Pharma Inc.

MULTI-VITAMIN WITH FLUORIDE 
multi-vitamin with fluoride tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51862-152
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A ACETATE (VITAMIN A) VITAMIN A 2500 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL 15 [iU]
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE HYDROCHLORIDE 1.05 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.2 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 13.5 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 1.05 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 0.3 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 4.5 ug
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.5 mg
Inactive Ingredients
Ingredient Name Strength
CHERRY  
ORANGE  
GRAPE  
SUCROSE  
D&C RED NO. 7  
SODIUM ASCORBATE  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 6  
MAGNESIUM STEARATE  
MICROCRYSTALLINE CELLULOSE  
POLYETHYLENE GLYCOL, UNSPECIFIED  
STEARIC ACID  
Product Characteristics
Color ORANGE, RED, PURPLE Score no score
Shape ROUND Size 13mm
Flavor ORANGE, GRAPE, CHERRY Imprint Code 152
Contains     
Packaging
# Item Code Package Description
1 NDC:51862-152-01 100 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/21/2011 06/30/2019
Labeler - Mayne Pharma Inc (867220261)
Revised: 07/2017   Mayne Pharma Inc
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