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MVC (sodium fluoride 1 mg vitamin a palmitate 2500 [iu] ascorbic acid 60 mg cholecalciferol 400 [iu] .alpha.-tocopherol acetate 15 [iu] thiamine mononitrate 1.05 mg riboflavin 1.2 mg niacinamide 13.5 mg pyridoxine hydrochloride 1.05 mg folic acid 0.3 mg cyanocobalamin 4.5 ug) Dailymed


Generic: sodium fluoride, vitamin a palmitate, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid and cyanocobalamin is used for the treatment of Beriberi Pellagra Thiamine Deficiency Wernicke Encephalopathy Alcoholic Neuropathy Dermatitis Malabsorption Syndromes Night Blindness Photosensitivity Disorders Vitamin A Deficiency Xerophthalmia Anemia, Pernicious Diabetic Neuropathies Multiple Sclerosis Vitamin B 12 Deficiency Alzheimer Disease Anemia, Hemolytic Bronchopulmonary Dysplasia Dyskinesia, Drug-Induced Vitamin E Deficiency Common Cold Hyperoxaluria Methemoglobinemia Scurvy Wounds, Penetrating Tyrosinemias Cardiovascular Diseases Crohn Disease Hypoparathyroidism Kidney Failure, Chronic Lung Neoplasms Osteoporosis Psoriasis Skin Neoplasms Familial Hypophosphatemic Rickets Vitamin B 6 Deficiency Anemia, Aplastic Anemia, Megaloblastic Folic Acid Deficiency Neural Tube Defects Anemia, Iron-Deficiency Coronary Artery Disease Diarrhea Flatulence Flushing Hemorrhage Hypercholesterolemia Hypotension Liver Diseases Peptic Ulcer Hypertriglyceridemia Peripheral Vascular Diseases Riboflavin Deficiency Dental Caries Dental Plaque Tooth Loss


IMPRINT: SCI 1001     SHAPE: round
    COLOR: white

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Health Claim Section


Rx only

Statement Of Identity Section

Nutrition Facts Serving Size 1 Chewable Tablet Serving Per Container 30 or 90
Amount Per Serving (1 Chewable Tablet) 1.0 mg 0.5 mg 0.25 mg %DV Adults & Children 4 Years or More
Vitamin A 2500 IU 2500 IU 2500 IU 50%
Vitamin C 60 mg 60 mg 60 mg 100%
Vitamin D 400 IU 400 IU 400 IU 100%
Vitamin E 15 IU 15 IU 15 IU 50%
Thiamin 1.05 mg 1.05 mg 1.05 mg 70%
Riboflavin 1.2 mg 1.2 mg 1.2 mg 70%
Niacin 13.5 mg 13.5 mg 13.5 mg 68%
Vitamin B6 1.05 mg 1.05 mg 1.05 mg 53%
Folate 0.3 mg 0.3 mg 0.3 mg 75%
Vitamin B12 4.5 mcg 4.5 mcg 4.5 mcg 75%
Fluoride 1.0 mg 0.5 mg 0.25 mg Daily Value (%DV) not established

Active ingredients


Fluoride as sodium fluoride.

Other Ingredients


Xylitol, microcrystalline cellulose, mannitol, talc, magnesium stearate, sucralose, natural flavors, citric acid.

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 forms to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:



Three stages of fluoride deposition in tooth enamel can be distinguished:
  • Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.
  • After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.
  • 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 fluoride and ten essential vitamins.

Multivitamin with 1.0 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.

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


Keep this and all medication out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Should be chewed. This product, as with 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:
  • Determine the fluoride content of the drinking water from all major sources.
  • Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste.
  • 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 or as prescribed.

How Supplied


Multivitamin with 1.0 mg, 0.5 mg and 0.25 mg Fluoride Chewable Tablets are all available in 30 and 90 tablet bottles.

STORAGE


Store in a cool dry place. Protect from light and moisture.

Health Claim Section


Manufactured by: Sancilio & Company, Inc. 3874 Fiscal Court #200 Riviera Beach, FL 33404

Principal Display Panel - 1.0 Mg Bottle Label


44946-1014-5

SCI Sancilio & Company, Inc. Developing Good Science into Great Medicine

MVC â„¢-Fluoride 1.0mg* Multivitamin Chewable Tablets with Fluoride

No dyes, artificial flavors or sugar

DietarySupplement

90 tabletsMade in the U.S.A.

Principal Display Panel - 0.5mg Bottle Label


SCI Sancilio & Company, Inc. Developing Good Science into Great Medicine

44946-1013-5 Rx Only

MVC ® Fluoride 0.5mg * MULTIVITAMIN WITH FLUORIDE CHEWABLE TABLETS

NO DYES, ARTIFICIAL FLAVORS OR SUGAR SACCHARIN AND GLUTEN FREE

MULTIVITAMIN AND FLUORIDE SUPPLEMENT

90 Tablets Made in the U.S.A.

Principal Display Panel - 0.25mg Bottle Label


SCI Sancilio & Company, Inc. Developing Good Science into Great Medicine

44946-1012-5 Rx Only

MVC ® Fluoride 0.25mg * MULTIVITAMIN WITH FLUORIDE CHEWABLE TABLETS

NO DYES, ARTIFICIAL FLAVORS OR SUGAR SACCHARIN AND GLUTEN FREE

MULTIVITAMIN AND FLUORIDE SUPPLEMENT

90 Tablets Made in the U.S.A.

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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