MULTIVITAMIN WITH FLUORIDE - sodium fluoride tablet, chewable 
PureTek Corporation

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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Prescribing Information

MULTIVITAMIN WITH FLUORIDE vitamin A, ascorbic acid, sodium ascorbate, cholecalciferol, alpha-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid and cyanocobalamin tablet, chewable

Each Fluoride Chewable Tablet Contains:

Nutrition Facts

Dosage Size 1 Chewable Tablet

Amount per tablet        0.25 mg         %DV Adults and Children 4 years or More
Vitamin A                          2500 IU                    50%
Vitamin C                          60 mg                      100%
VItamin D                          400 IU                      100%
Vitamin E                          15 IU                        50%
Thiamine                           1.05 mg                    70%
Riboflavin                          1.2 mg                      71%
Niacin                               13.5 mg                    68%
Vitamin B6                        1.05 mg                    53%
Folate                               300 mcg                   75%
Vitamin B12                       4.5 mcg                    75%
Fluoride                             0.25 mg                      *

*daily value (DV) not established

Multivitamin with Fluoride 0.25 mg active ingredient for caries prophylaxis: Fluoride as sodium fluoride

Multivitamin with 0.25 mg Fluoride Chewable Tablets
provide sodium fluoride and ten essential vitamins in a chewable tablet.

Other ingredients: ascorbic acid, cholecalciferol, compressible sugar, croscarmellose sodium, dl-alpha tocopheryl acetate, D and C Red #27 aluminum lake, FD and C Blue #1 aluminum lake, folic acid, grape flavor, magnesium stearate, microcrystalline cellulose, niacinamide, pyridoxine, riboflavin, sodium ascorbate, stearic acid, thiamine, vitamin A, vitamin B12.

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 0.25 mg 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.

INDICATIONS AND USAGE

Supplementation of the diet with ten essential vitamins.

Supplementation of the diet with fluoride for caries prophylaxis.

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

Multivitamin with 0.25 mg Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamine, 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 supplements.

Children using Multivitamin with 0.25 mg Fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.

Multivitamin with Fluoride Chewable Tablets is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.



WARNING


Keep out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Caution: Do not eat or drink dairy products within one hour of fluoride administration.

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 0.25 mg Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

Before prescribing Multivitamin with 0.25 mg 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.




ADVERSE REACTIONS

Allergic rash and other idiosyncrasies have been rarely reported.

DOSAGE AND ADMINISTRATION


One tablet daily, to be dissolved in the mouth or chewed before swallowing. Do not give a chewable tablet to a child younger than 4 years old.

HOW SUPPLIED

Multivitamin Chewable tablets containing 0.25 mg fluoride are purple-colored, grape flavor, un-scored, round debossed "107" tablets are available on prescription only in bottles of 100 tablets. NDC: 59088-107-59.



STORAGE

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.

Dispense in a tight, light resistant container with a child-resistant closure as defined in the USP/NF. All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

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MULTIVITAMIN WITH FLUORIDE 
sodium fluoride tablet, chewable
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-107
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.25 mg
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A2500 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID24 mg
SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) SODIUM ASCORBATE36 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE, DL-15 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE - UNII:X66NSO3N35) THIAMINE1.05 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.2 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE13.5 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE1.05 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID300 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN4.5 ug
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorpurple (Dark purple) Scoreno score
ShapeROUNDSize13mm
FlavorGRAPE (Grape flavor) Imprint Code 107
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-107-59100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2011
Labeler - PureTek Corporation (785961046)
Establishment
NameAddressID/FEIBusiness Operations
PureTek Corporation785961046manufacture, label, pack, outsourcing human drug compounding, relabel, repack

Revised: 5/2011
Document Id: 314c4eba-6a4e-480c-b6da-ae849c15ce07
Set id: 4cb0eca0-aa84-4bcd-bebf-2ef41ca70e10
Version: 1
Effective Time: 20110519
 
PureTek Corporation