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

----------

MULTIVITAMIN WITH FLUORIDE
CHEWABLE TABLETS

Rx only

Nutrition Facts
Serving Size 1 Chewable Tablet
Serving Per Container 30 or 90
Amount Per Serving
(1 Chewable Tablet)
1.0 mg0.5 mg0.25 mg%DV Adults & Children
4 Years or More
*
Daily Value (%DV) not established
Vitamin A2500 IU2500 IU2500 IU50%
Vitamin C60 mg60 mg60 mg100%
Vitamin D400 IU400 IU400 IU100%
Vitamin E15 IU15 IU15 IU50%
Thiamin1.05 mg1.05 mg1.05 mg70%
Riboflavin1.2 mg1.2 mg1.2 mg70%
Niacin13.5 mg13.5 mg13.5 mg68%
Vitamin B61.05 mg1.05 mg1.05 mg53%
Folate0.3 mg0.3 mg0.3 mg75%
Vitamin B124.5 mcg4.5 mcg4.5 mcg75%
Fluoride1.0 mg0.5 mg0.25 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:

Chemical Structure

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.

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 - 1.0 mg Bottle Label

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 - 0.5mg Bottle Label

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.

PRINCIPAL DISPLAY PANEL - 0.25mg Bottle Label
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 TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:44946-1014
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1 mg
Vitamin A Palmitate (UNII: 1D1K0N0VVC) (Vitamin A - UNII:81G40H8B0T, Retinol - UNII:G2SH0XKK91) Vitamin A2500 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol400 [iU]
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol15 [iU]
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine1.05 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.2 mg
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide13.5 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride1.05 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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:44946-1014-44 in 1 BOX
124 in 1 BOX
130 in 1 BOTTLE
2NHRIC:44946-1014-54 in 1 BOX
224 in 1 BOX
290 in 1 BOTTLE
3NHRIC:44946-1014-630 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Dietary Supplement12/20/2009
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
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 TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:44946-1013
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 Palmitate (UNII: 1D1K0N0VVC) (Vitamin A - UNII:81G40H8B0T, Retinol - UNII:G2SH0XKK91) Vitamin A2500 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol400 [iU]
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol15 [iU]
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine1.05 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.2 mg
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide13.5 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride1.05 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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:44946-1013-44 in 1 BOX
124 in 1 BOX
130 in 1 BOTTLE
2NHRIC:44946-1013-54 in 1 BOX
224 in 1 BOX
290 in 1 BOTTLE
3NHRIC:44946-1013-630 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Dietary Supplement12/20/2009
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
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 TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:44946-1012
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.25 mg
Vitamin A Palmitate (UNII: 1D1K0N0VVC) (Vitamin A - UNII:81G40H8B0T, Retinol - UNII:G2SH0XKK91) Vitamin A2500 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol400 [iU]
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol15 [iU]
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine1.05 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.2 mg
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide13.5 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride1.05 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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:44946-1012-77 in 1 BOTTLE, PLASTIC
2NHRIC:44946-1012-44 in 1 BOX
224 in 1 BOX
230 in 1 BOTTLE
3NHRIC:44946-1012-54 in 1 BOX
324 in 1 BOX
390 in 1 BOTTLE
4NHRIC:44946-1012-630 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Dietary Supplement12/20/2009
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 Inc080018491MANUFACTURE, RELABEL, REPACK

Revised: 2/2018
Document Id: 7a75127a-9af0-46c5-aa67-9ab1996ec8d3
Set id: 50b44fd6-8747-448f-b951-234e7e17df4f
Version: 6
Effective Time: 20180226
 
Sancilio & Company Inc