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MVC-Fluoride: Package Insert / Prescribing Info

Package insert / product label
Generic name: sodium fluoride, vitamin a, ascorbic acid, vitamin d, alpha-tocopherol, thiamine, riboflavin, niacin, pyridoxine, folic acid and cyanocobalamin
Dosage form: tablet, chewable
Drug class: Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Feb 28, 2024.

Each Multivitamin with 0.5 mg Fluoride Tablet Contains:
*
Each Multivitamin with 0.5 mg Fluoride Tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride (NaF).
Vitamin A (as Palmitate)2500 IU
Vitamin C60 mg
Vitamin D400 IU
Vitamin E15 IU
Thiamine1.05 mg
Riboflavin1.2 mg
Niacin13.5 mg
Vitamin B61.05 mg
Folate (as Folic Acid)0.3 mg
Vitamin B124.5 mcg
Fluoride (as Sodium Fluoride)*0.5 mg

Warnings

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222. TABLET SHOULD BE CHEWED. THIS PRODUCT, AS WITH ALL CHEWABLE TABLETS, IS NOT RECOMMENDED FOR CHILDREN UNDER AGE 4 DUE TO RISK OF CHOKING.

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

MVC-Fluoride Dosage and Administration

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 "5" on the other.

Precautions

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.

Other Ingredients

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

Storage

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

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.

Manufactured by: Sancilio & Co., Inc.
Riviera Beach, FL 33404 USA

rev. 11/18/11

PRINCIPAL DISPLAY PANEL - 0.5 mg Tablet Bottle Label

44946-1021-5

Sancilio &
Company, Inc.

Developing Good Science into Great Medicine

MVC®- Fluoride
Multivitamin with Fluoride
Chewable Tablets

NO DYES, ARTIFICIAL FLAVORS OR SUGAR
SACCHARIN AND GLUTEN FREE
CONTAINS XYLITOL

0.5
mg

Dispense under a
physician's order

Dietary
Supplement

90 tablets

PRINCIPAL DISPLAY PANEL - 0.5 mg Tablet Bottle Label
MVC-FLUORIDE
sodium fluoride, vitamin a, ascorbic acid, vitamin d, alpha-tocopherol, thiamine, riboflavin, niacin, pyridoxine, folic acid, and cyanocobalamin tablet, chewable
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:44946-1021
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.5 mg
Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A2500 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 mg
Vitamin D (UNII: 9VU1KI44GP) (Vitamin D - UNII:9VU1KI44GP) Vitamin D400 [iU]
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL15 [iU]
Thiamine (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) Thiamine1.05 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.2 mg
Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin13.5 mg
Pyridoxine (UNII: KV2JZ1BI6Z) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine1.05 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid0.3 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin4.5 ug
Inactive Ingredients
Ingredient NameStrength
Xylitol (UNII: VCQ006KQ1E)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
Mannitol (UNII: 3OWL53L36A)
Talc (UNII: 7SEV7J4R1U)
Magnesium Stearate (UNII: 70097M6I30)
Sucralose (UNII: 96K6UQ3ZD4)
Anhydrous Citric Acid (UNII: XF417D3PSL)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:44946-1021-590 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Dietary Supplement12/07/2011
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)13 mm
imprint
flavor
Labeler - Sancilio & Company Inc. (176681257)
Establishment
NameAddressID/FEIBusiness Operations
Sancilio & Company Inc.176681257MANUFACTURE(44946-1021)