MVC- sodium fluoride, vitamin a palmitate, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid and cyanocobalamin tablet, chewable

MVC by

Drug Labeling and Warnings

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

Drug Details [pdf]

HEALTH CLAIM

Rx only

STATEMENT OF IDENTITY

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
* Daily Value (%DV) not established
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	*

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:

1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.
2. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.
3. 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:

1. Determine the fluoride content of the drinking water from all major sources.
2. Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste.
3. 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

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 ™-Fluoride 1.0mg*
Multivitamin Chewable Tablets with Fluoride

No dyes, artificial flavors or sugar

Dietary
Supplement

90 tablets
Made 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.

INGREDIENTS AND APPEARANCE

MVC 
sodium fluoride, vitamin a palmitate, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid and cyanocobalamin tablet, chewable

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:44946-1014
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	1 mg
Vitamin A Palmitate (UNII: 1D1K0N0VVC) (Vitamin A - UNII:81G40H8B0T, Retinol - UNII:G2SH0XKK91)	Vitamin A	2500 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	60 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41)	Cholecalciferol	400 [iU]
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) (.Alpha.-Tocopherol - UNII:H4N855PNZ1)	.Alpha.-Tocopherol	15 [iU]
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J)	Thiamine	1.05 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR)	Riboflavin	1.2 mg
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4)	Niacinamide	13.5 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z)	Pyridoxine Hydrochloride	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
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Malic Acid (UNII: 817L1N4CKP)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Sucralose (UNII: 96K6UQ3ZD4)
Xylitol (UNII: VCQ006KQ1E)
Talc (UNII: 7SEV7J4R1U)
Magnesium Stearate (UNII: 70097M6I30)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:44946-1014-4	4 in 1 BOX
1		24 in 1 BOX
1		30 in 1 BOTTLE
2	NHRIC:44946-1014-5	4 in 1 BOX
2		24 in 1 BOX
2		90 in 1 BOTTLE
3	NHRIC:44946-1014-6	30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement		12/20/2009

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	12 mm
imprint
flavor

MVC 
sodium fluoride, vitamin a palmitate, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid and cyanocobalamin tablet, chewable

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:44946-1013
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	0.5 mg
Vitamin A Palmitate (UNII: 1D1K0N0VVC) (Vitamin A - UNII:81G40H8B0T, Retinol - UNII:G2SH0XKK91)	Vitamin A	2500 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	60 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41)	Cholecalciferol	400 [iU]
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) (.Alpha.-Tocopherol - UNII:H4N855PNZ1)	.Alpha.-Tocopherol	15 [iU]
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J)	Thiamine	1.05 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR)	Riboflavin	1.2 mg
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4)	Niacinamide	13.5 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z)	Pyridoxine Hydrochloride	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
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Malic Acid (UNII: 817L1N4CKP)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Sucralose (UNII: 96K6UQ3ZD4)
Xylitol (UNII: VCQ006KQ1E)
Talc (UNII: 7SEV7J4R1U)
Magnesium Stearate (UNII: 70097M6I30)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:44946-1013-4	4 in 1 BOX
1		24 in 1 BOX
1		30 in 1 BOTTLE
2	NHRIC:44946-1013-5	4 in 1 BOX
2		24 in 1 BOX
2		90 in 1 BOTTLE
3	NHRIC:44946-1013-6	30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement		12/20/2009

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	12 mm
imprint
flavor

MVC 
sodium fluoride, vitamin a palmitate, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid and cyanocobalamin tablet, chewable

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:44946-1012
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 Palmitate (UNII: 1D1K0N0VVC) (Vitamin A - UNII:81G40H8B0T, Retinol - UNII:G2SH0XKK91)	Vitamin A	2500 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	60 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41)	Cholecalciferol	400 [iU]
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) (.Alpha.-Tocopherol - UNII:H4N855PNZ1)	.Alpha.-Tocopherol	15 [iU]
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J)	Thiamine	1.05 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR)	Riboflavin	1.2 mg
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4)	Niacinamide	13.5 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z)	Pyridoxine Hydrochloride	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
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Malic Acid (UNII: 817L1N4CKP)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Sucralose (UNII: 96K6UQ3ZD4)
Xylitol (UNII: VCQ006KQ1E)
Talc (UNII: 7SEV7J4R1U)
Magnesium Stearate (UNII: 70097M6I30)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:44946-1012-7	7 in 1 BOTTLE, PLASTIC
2	NHRIC:44946-1012-4	4 in 1 BOX
2		24 in 1 BOX
2		30 in 1 BOTTLE
3	NHRIC:44946-1012-5	4 in 1 BOX
3		24 in 1 BOX
3		90 in 1 BOTTLE
4	NHRIC:44946-1012-6	30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement		12/20/2009

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		080018491	MANUFACTURE, RELABEL, REPACK