MVC ® - Fluoride Multivitamin with Fluoride Chewable Tablets

Manufacturer
Sancilio & Company Inc.
Effective date
2018-02-15
Label type
DIETARY SUPPLEMENT
Version
4
Source
full-release
Hydrated at
2026-06-01 02:48:50

Label at a glance#

ProductMVC-Fluoride
Active ingredientSodium Fluoride, Vitamin A, Ascorbic Acid, Vitamin D, .ALPHA.-TOCOPHEROL, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, Cyanocobalamin
Label structure10 sections

Dosage and administration

USE AS DIRECTED BY YOUR PHYSICIAN.

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Each Multivitamin with 0.25 mg Fluoride Tablet Contains:
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)* 0.25 mg

* Each Multivitamin with 0.25 mg Fluoride Tablet contains 0.25 mg Fluoride from 0.55 mg Sodium Fluoride (NaF).

WARNING

WARNINGS SECTION

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

HEALTH CLAIM SECTION

USE AS DIRECTED BY YOUR PHYSICIAN.

Description

HEALTH CLAIM SECTION

Off-white to pale yellow, speckled, fruit flavor, round-shaped chewable tablet debossed "SCI" on one side and "1" on the other.

Caution

PRECAUTIONS SECTION

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

HEALTH CLAIM SECTION

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

Storage

HEALTH CLAIM SECTION

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 SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL - 0.25 mg Tablet Bottle Label
PRINCIPAL DISPLAY PANEL - 0.25 mg Tablet Bottle Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NIACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
VITAMIN A Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44946-1020-5MVC-Fluoride90 in 1 BOTTLETABLET, CHEWABLE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44946-1020MVC-FLUORIDE (SODIUM FLUORIDE, VITAMIN A, ASCORBIC ACID, VITAMIN D, ALPHA-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACIN, PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET, CHEWABLE [SANCILIO & COMPANY INC.]41 package rows20180221_ee94954f-ec49-4a10-8af9-c667603cefce.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44946-1020-5EA - Each44946-10207350f7be-55e0-4998-a320-dabdccb9e51112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Alpha-TocopherolACTIVE INGREDIENTH4N855PNZ11
Ascorbic AcidACTIVE INGREDIENTPQ6CK8PD0R1
CyanocobalaminACTIVE INGREDIENTP6YC3EG2041
Folic AcidACTIVE INGREDIENT935E97BOY81
NiacinACTIVE INGREDIENT2679MF687A1
PyridoxineACTIVE INGREDIENTKV2JZ1BI6Z1
RiboflavinACTIVE INGREDIENTTLM2976OFR1
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W71
ThiamineACTIVE INGREDIENTX66NSO3N351
Vitamin AACTIVE INGREDIENT81G40H8B0T1
Vitamin DACTIVE INGREDIENT9VU1KI44GP1
Alpha-TocopherolACTIVE MOIETYH4N855PNZ11
Ascorbic AcidACTIVE MOIETYPQ6CK8PD0R1
CyanocobalaminACTIVE MOIETYP6YC3EG2041
Fluoride IonACTIVE MOIETYQ80VPU408O1
Folic AcidACTIVE MOIETY935E97BOY81
NiacinACTIVE MOIETY2679MF687A1
PyridoxineACTIVE MOIETYKV2JZ1BI6Z1
RiboflavinACTIVE MOIETYTLM2976OFR1
ThiamineACTIVE MOIETYX66NSO3N351
Vitamin AACTIVE MOIETY81G40H8B0T1
Vitamin DACTIVE MOIETY9VU1KI44GP1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61U1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QP1
Magnesium StearateINACTIVE INGREDIENT70097M6I301
MannitolINACTIVE INGREDIENT3OWL53L36A1
SucraloseINACTIVE INGREDIENT96K6UQ3ZD41
TalcINACTIVE INGREDIENT7SEV7J4R1U1
XylitolINACTIVE INGREDIENTVCQ006KQ1E1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44946-102044946-1020-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 289 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TalcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ACAPSULE, EXTENDED RELEASE / ORAL160 mgExact identifier — unii candidate
65 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPDROPS / ORALNAExact identifier — unii candidate
88 equally ranked IID candidates
TalcTALC7SEV7J4R1UDROPS / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ATABLET / SUBLINGUAL495 mgExact identifier — unii candidate
65 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii candidate
39 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30INHALANT / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL357 mgExact identifier — unii candidate
35 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE / ORAL1725 mgExact identifier — unii candidate
28 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET / ORAL914 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / AURICULAR (OTIC)0.04 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET / SUBLINGUAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii candidate
22 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1ESOLUTION / ORAL21600 mgExact identifier — unii candidate
12 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
TalcTALC7SEV7J4R1UCAPSULE / ORAL729 mgExact identifier — unii candidate
35 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ATABLET / BUCCAL360 mgExact identifier — unii candidate
65 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UIMPLANT / INTRAVITREAL1.66 mgExact identifier — unii candidate
28 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ASOLUTION / ORAL869 mgExact identifier — unii candidate
65 equally ranked IID candidates
MannitolMANNITOL3OWL53L36AINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS181 mgExact identifier — unii candidate
65 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / ORAL315 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, CHEWABLE / ORAL7 mgExact identifier — unii candidate
88 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ASOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC4.35 %w/wExact identifier — unii candidate
65 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET / RECTAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAVENOUS10 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSWAB / TOPICAL0.05 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30WAFER / ORAL66 mgExact identifier — unii candidate
39 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ASPRAY / NASAL41.5 mgExact identifier — unii candidate
65 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / INTRAVENOUS0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS385 mgExact identifier — unii candidate
88 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, DELAYED RELEASE / ORAL349 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii candidate
35 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ASOLUTION, CONCENTRATE / INTRAVENOUS220 mgExact identifier — unii candidate
65 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTROCHE / ORAL12 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPCONCENTRATE / ORAL5.3 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
MannitolMANNITOL3OWL53L36APOWDER, FOR SOLUTION / ORAL3767 mgExact identifier — unii candidate
65 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET / SUBLINGUAL24 mgExact identifier — unii candidate
88 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET / SUBLINGUAL12 mgExact identifier — unii candidate
22 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, COATED PELLETS / ORAL456 mgExact identifier — unii candidate
28 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / SUBCUTANEOUS26 mgExact identifier — unii candidate
88 equally ranked IID candidates
TalcTALC7SEV7J4R1ULOZENGE / ORAL50 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
35 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION/ DROPS / ORAL19 mgExact identifier — unii candidate
88 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii candidate
28 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1ESUSPENSION / ORAL1500 mgExact identifier — unii candidate
12 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii candidate
35 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, FILM COATED / ORAL42 mgExact identifier — unii candidate
88 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii candidate
39 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ALOZENGE / ORAL20546 mgExact identifier — unii candidate
65 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30GRANULE, FOR SUSPENSION / ORAL14 mgExact identifier — unii candidate
39 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING / ORAL83 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SUSPENSION / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
22 equally ranked IID candidates
MannitolMANNITOL3OWL53L36AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS658 mgExact identifier — unii candidate
65 equally ranked IID candidates
TalcTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
28 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1588d73a-77b3-4d69-a177-1ef8cb2e9a26ee94954f-ec49-4a10-8af9-c667603cefce2018-02-15WarningsExact identifier
spl set id: ee94954f-ec49-4a10-8af9-c667603cefce

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.