MULTI VITAMIN WITH FLUORIDE- sodium fluoride, vitamin a acetate, ascorbic acid, sodium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid and cyanocobalamin tablet, chewable 
Qualitest Pharmaceuticals

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.

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MULTI-VITAMIN WITH FLUORIDE CHEWABLE TABLETS GRAPE

Rx only

This is an image of the Nutrition Facts panel.

Active ingredient for caries prophylaxis:  Fluoride as sodium fluoride.

Other Ingredients:

Artificial grape flavor, ascorbic acid, cholecalciferol, compressible sugar, D&C Red #7 calcium lake, FD&C Blue #1 aluminum lake, folic acid, magnesium stearate, microcrystalline cellulose, niacinamide, polyethylene glycol, pyridoxine, riboflavin, sodium ascorbate, stearic acid, thiamine, vitamin A acetate, vitamin B12 and vitamin E acetate.

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.

Multivitamin 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:

This is an image of the reaction between hydroxyapatite and 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.

INDICATIONS AND USAGE

Supplementation of the diet with ten essential vitamins.

Supplementation of the diet with fluoride for caries prophylaxis.

Multivitamin with 1 mg Fluoride Chewable Tablets provide fluoride in tablet form for children 6-16 years of age in areas where the water fluoride level is less than 0.3 ppm.

Multivitamin with 0.5 mg Fluoride Chewable Tablets provide fluoride in tablet form for children 4-6 years of age where the water fluoride level is less than 0.3 ppm, and for children 6 years of age and above where the drinking water contains 0.3 through 0.6 ppm of fluoride.

Multivitamin with 0.25 mg Fluoride Chewable Tablets provide fluoride in tablet form for children 4-6 years of age where the drinking water contains 0.3 through 0.6 ppm of fluoride.

Multivitamin with Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6, vitamin B12, and folate 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 ten essential vitamins and the important mineral, fluoride.

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.

Children using Multivitamin with Fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.

WARNING

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

Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.

PRECAUTIONS

The suggested dose of Multivitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

Before prescribing Multivitamin with Fluoride Chewable Tablets:

  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.

Do not eat or drink dairy products within one hour of medication administration.

ADVERSE REACTIONS

Allergic rash and other idiosyncrasies have been rarely reported.

DOSAGE AND ADMINISTRATION

One tablet daily or as prescribed.

HOW SUPPLIED

Multi-vitamin with Fluoride Chewable Tablets Grape are available as follows:

Manufactured for:
QUALITEST PHARMACEUTICALS
130 Vintage Drive
Huntsville, AL 35811

8183001
R10/12-R3

PRINCIPAL DISPLAY PANEL

This is an image of the label for 0.25mg Multi-Vitamin with Fluoride Chewable Tablets.

PRINCIPAL DISPLAY PANEL

This is an image of the label for 0.5mg Multi-Vitamin with Fluoride Chewable Tablets.

PRINCIPAL DISPLAY PANEL

This is an image of the label for 1 mg Multi-Vitamin with Fluoride Chewable Tablets.
MULTI VITAMIN WITH FLUORIDE 
multi vitamin with fluoride tablet, chewable
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0603-4381
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE0.25 mg
VITAMIN A ACETATE (VITAMIN A) VITAMIN A ACETATE2500 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID24 mg
SODIUM ASCORBATE (ASCORBIC ACID) SODIUM ASCORBATE36 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL-15 [iU]
THIAMINE MONONITRATE (Thiamine ION) THIAMINE MONONITRATE1.05 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN1.2 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE13.5 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE1.05 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID0.3 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN4.5 ug
Inactive Ingredients
Ingredient NameStrength
RAW SUGAR 
D&C RED NO. 7 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize13mm
FlavorGRAPEImprint Code 4378;V
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-4381-21100 in 1 BOTTLE, PLASTIC
2NDC:0603-4381-28500 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER10/09/2009
MULTI VITAMIN WITH FLUORIDE 
multi vitamin with fluoride tablet, chewable
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0603-4382
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE0.5 mg
VITAMIN A ACETATE (VITAMIN A) VITAMIN A ACETATE2500 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID24 mg
SODIUM ASCORBATE (ASCORBIC ACID) SODIUM ASCORBATE36 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL-15 [iU]
THIAMINE MONONITRATE (Thiamine ION) THIAMINE MONONITRATE1.05 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN1.2 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE13.5 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE1.05 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID0.3 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN4.5 ug
Inactive Ingredients
Ingredient NameStrength
RAW SUGAR 
D&C RED NO. 7 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
Product Characteristics
ColorPURPLEScoreno score
ShapeSQUARESize13mm
FlavorGRAPEImprint Code 4379;V
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-4382-21100 in 1 BOTTLE, PLASTIC
2NDC:0603-4382-28500 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER10/09/2009
MULTI VITAMIN WITH FLUORIDE 
multi vitamin with fluoride tablet, chewable
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0603-4383
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE1 mg
VITAMIN A ACETATE (VITAMIN A) VITAMIN A ACETATE2500 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID24 mg
SODIUM ASCORBATE (ASCORBIC ACID) SODIUM ASCORBATE36 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL-15 [iU]
THIAMINE MONONITRATE (Thiamine ION) THIAMINE MONONITRATE1.05  mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN1.2 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE13.5 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE1.05 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID0.3 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN4.5 ug
Inactive Ingredients
Ingredient NameStrength
RAW SUGAR 
D&C RED NO. 7 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize13mm
FlavorGRAPEImprint Code 4380;V
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-4383-21100 in 1 BOTTLE, PLASTIC
2NDC:0603-4383-28500 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER10/09/2009
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIBusiness Operations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE(0603-4381, 0603-4382, 0603-4383)

Revised: 11/2012
Document Id: 9c0105e7-b917-4b83-900a-61cee911d66b
Set id: 378704e2-1d34-4816-b8e7-56b1d17bff27
Version: 15
Effective Time: 20121130
 
Qualitest Pharmaceuticals