MVC-FLUORIDE- sodium fluoride, vitamin a, ascorbic acid, vitamin d, alpha-tocopherol, thiamine, riboflavin, niacin, pyridoxine, folic acid, and cyanocobalamin tablet, chewable

MVC-Fluoride by

Drug Labeling and Warnings

MVC-Fluoride by is a Other medication manufactured, distributed, or labeled by Sancilio & Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Each Multivitamin with 0.25 mg Fluoride Tablet Contains:
* Each Multivitamin with 0.25 mg Fluoride Tablet contains 0.25 mg Fluoride from 0.55 mg Sodium Fluoride (NaF).
Vitamin A (as Palmitate)	2500 IU
Vitamin C	60 mg
Vitamin D	400 IU
Vitamin E	15 IU
Thiamine	1.05 mg
Riboflavin	1.2 mg
Niacin	13.5 mg
Vitamin B6	1.05 mg
Folate (as Folic Acid)	0.3 mg
Vitamin B12	4.5 mcg
Fluoride (as Sodium Fluoride)*	0.25 mg

WARNING

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

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.

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.

DOSAGE & ADMINISTRATION

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.

HEALTH CLAIM

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 - 0.25 mg Tablet Bottle Label

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

44946-1020-5

MVC®- Fluoride
Multivitamin with Fluoride
Chewable Tablets

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

0.25
mg

Dispense under a
physician's order†

Dietary
Supplement

90 tablets

INGREDIENTS AND APPEARANCE

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 Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:44946-1020
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	0.25 mg
Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T)	Vitamin A	2500 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	60 mg
Vitamin D (UNII: 9VU1KI44GP) (Vitamin D - UNII:9VU1KI44GP)	Vitamin D	400 [iU]
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL	15 [iU]
Thiamine (UNII: X66NSO3N35) (Thiamine Ion - UNII:4ABT0J945J)	Thiamine	1.05 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR)	Riboflavin	1.2 mg
Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A)	Niacin	13.5 mg
Pyridoxine (UNII: KV2JZ1BI6Z) (Pyridoxine - UNII:KV2JZ1BI6Z)	Pyridoxine	1.05 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	0.3 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204)	Cyanocobalamin	4.5 ug

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:44946-1020-5	90 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement		12/07/2011

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	13 mm
imprint
flavor

Labeler - Sancilio & Company Inc. (176681257)

Establishment
Name	Address	ID/FEI	Business Operations
Sancilio & Company Inc.		176681257	MANUFACTURE(44946-1020)