Description
SCI
Developing Good Science into Great Medicine Product Characteristics
Color WHITE (Off white to pale yellow) Score no score
Shape ROUND Size 13mm
Flavor FRUIT Imprint Code SCI:1
Contains
PRINCIPAL DISPLAY PANEL - 0.25 mg Tablet Bottle Label Packaging
# Item Code Package Description Mutlilevel Packaging
1 NDC:44945-1020-5 90 TABLET, CHEWABLE (TABLET) in 1 BOTTLE None 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. Made in U.S.A. 0.25 MG 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 Description: Off-white to pale yellow, speckled, fruit flavor, round-shaped chewable tablet debossed "SCI" on one side and " 1" on the other. Rx Only
Formulation
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
Multivitamin with Fluoride Chewable Tablets 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.] Inactive Ingredients
Ingredient Name Strength
Xylitol
Cellulose, Microcrystalline
Mannitol
Talc
Magnesium Stearate
Talc
Sucralose
Citric Acid Monohydrate CONTAINS XYLITOL NO DYES, ARTIFICIAL FLAVORS OR SUGAR
SACCHARIN AND GLUTEN FREE
Precautions
Caution: Do not use this product if you are allergic to any of the ingredients. DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING 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. IF OVERDOSE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATLEY 1-800-222-1222 CONTAINS XYLITOL