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Multivitamin with Fluoride Chewable Tablets

Package insert / prescribing information
Dosage form: tablet, chewable
Drug class: Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Sep 1, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

DESCRIPTION:

Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Stearic Acid (vegetable source), Sucrose, CI 45410 (Red 27 Lake), CI 42090 (FD&C Blue No. 1 Aluminum Lake).

Multivitamin with Fluoride Chewable Tablets - 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 0.5 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:

Ca 10(PO 4) 6(OH) 2 + 2F- ------- Ca 10(PO 4) 6F 2 + 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 for Multivitamin with Fluoride Chewable Tablets

Supplementation of the diet with ten essential vitamins.
Supplementation of the diet with fluoride for caries prophylaxis.
The American Academy of Pediatrics recommends that children up to the age 16, in areas where drinking water contains less
than optimal levels of fluoride, receive daily fluoride supplementation.
Multivitamin with Fluoride 0.5 mg Chewable Tablets provide 0.5 mg fluoride in tablet form for children 4-6 years of
age in areas where the drinking 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 Fluoride 0.5 mg 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.
Children using Multivitamin with Fluoride 0.5 mg Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.

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.







PRECAUTION

The suggested dose of Multivitamin with Fluoride 0.5 mg Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.
Before prescribing Multivitamin with Fluoride 0.5 mg 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.

Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet.

Adverse Reactions

Allergic rash and other idiosyncrasies have been rarely reported.

Multivitamin with Fluoride Chewable Tablets 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 is Multivitamin with Fluoride Chewable Tablets Supplied

Multivitamin chewable tablets containing 0.5 mg fluoride are purple-colored, grape flavor, un-scored, square debossed
“108” tablets are available on prescription only in bottles of 100 tablets. NDC: 59088-108-59

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.

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.

Multivitamin with Fluoride Chewable Tablets 0.5 mg

Manufactured By: PureTek Corporation
Panorama City, CA 91402

MULTIVITAMIN WITH FLUORIDE
sodium fluoride tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59088-108
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.5 mg
VITAMIN A (VITAMIN A) VITAMIN A 750 ug
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 24 mg
SODIUM ASCORBATE (ASCORBIC ACID) ASCORBIC ACID 36 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 10 ug
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 10 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 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 300 ug
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 4.5 ug
Inactive Ingredients
Ingredient Name Strength
SUCROSE
CROSCARMELLOSE SODIUM
D&C RED NO. 27
FD&C BLUE NO. 1
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STEARIC ACID
ASPARTAME
Product Characteristics
Color purple (Dark purple) Score no score
Shape SQUARE Size 13mm
Flavor GRAPE (Grape flavor) Imprint Code 108
Contains
Packaging
# Item Code Package Description
1 NDC:59088-108-59 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2011
Labeler - PureTek Corporation (785961046)
PureTek Corporation