MVC-Fluoride 0.25 mg

SCI Developing Good Science into Great Medicine

Multivitamin with Fluoride Chewable Tablets

NO DYES, ARTIFICIAL FLAVORS OR SUGAR SACCHARIN AND GLUTEN FREE

CONTAINS XYLITOL

Made in U.S.A.

Description Off-white to pale yellow, speckled, fruit flavor, round-shaped chewable tablet debossed "SCI" on one side and "1" on the other.

rev. 11/18/11

Inactive Ingredients Ingredient Name Strength Xylitol Cellulose, Microcrystalline Mannitol Talc Magnesium Stearate Talc Sucralose Citric Acid Monohydrate

Product Characteristics Color WHITE (Off white to pale yellow) Score no score Shape ROUND Size 13mm Flavor FRUIT Imprint Code SCI:1 Contains

Packaging # Item Code Package Description Mutlilevel Packaging 1 NDC:44945-1020-5 90 TABLET, CHEWABLE (TABLET) in 1 BOTTLE None

Rx Only

0.25 MG

MVC-FLUORIDE (sodium fluoride, vitamin a, ascorbic acid, vitamin d, alpha-tocopherol, thiamine, riboflavin, niacin, pyridoxine, folic acid, and cyanocobalamin) tablet, chewable [Sancilio & Company Inc.]

PRINCIPAL DISPLAY PANEL - 0.25 mg Tablet Bottle Label

Active Ingredients/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (Fluoride Ion) Sodium Fluoride 0.25 mg Vitamin A (Vitamin A) Vitamin A 2500 [IU] Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 60 mg Vitamin D (Vitamin D) Vitamin D 400 [IU] Alpha-Tocopherol (Alpha-Tocopherol) Alpha-Tocopherol 15 [IU] Thiamine (Thiamine) Thiamine 1.05 mg Riboflavin (Riboflavin) Riboflavin 1.2 mg Niacin (Niacin) Niacin 13.5 mg Pyridoxine (Pyridoxine) Pyridoxine 1.05 mg Folic Acid (Folic Acid) Folic Acid 0.3 mg Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 4.5 mg

NOTE: THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA.

DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING

Directions: USE AS DIRECTED BY YOUR PHYSICIAN.

Description: Off-white to pale yellow, speckled, fruit flavor, round-shaped chewable tablet debossed "SCI" on one side and " 1" on the other.

Caution: Do not use this product if you are allergic to any of the ingredients.

Take this product at least 2 hours before or after taking any products containing calcium (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives). Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis. Account for all daily sources of fluoride intake.

WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

TABLET SHOULD BE CHEWED. THIS PRODUCT, AS WITH ALL CHEWABLE TABLETS, IS NOT RECOMMENDED FOR CHILDREN UNDER AGE 4 DUE TO RISK OF CHOCKING.

This medical food product is formulated to be administered orally, under the ongoing supervision of a physician and is intended for the dietary management of dental caries for which a distinctive nutritional requirement of fluoride, based on recognized scientific principles, has been established by medical evaluation. The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health-insurance and state level reimbursement programs and is not intended to denote registration with the FDA.

CONTAINS XYLITOL

Storage: Store in a cool, dry place at room temperature 20(0) - 25(0)C (68(0) - 77(0)F) away from heat and sunlight. Store in original container.

IF OVERDOSE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATLEY 1-800-222-1222