MVC-Fluoride 0.25 mg

Basic Information

Product Label

Product label for MVC-Fluoride 0.25 mg
Full Name: MVC-Fluoride 0.25 mg
Brand: Sancilio & Company none
Product Type: Other Combinations
Physical State: Tablet or Pill
Product Version Code: Rev. 11/18/11

Contact Information

Manufactured by

Name: Sancilio & Co., Inc.
Address:Riviera Beach, FL, 33404
Country: USA
Types: Manufacturer

Product Details

Net Contents

90 Tablet(s)(90 Tablet(s))

Serving Sizes

Unit:Tablet(s)
Quantity:1 - 1
Daily Servings:1 - 1

Target Groups

Adult (18 - 50 Years)Gluten FreeSugar Free

Ingredients & Nutrition

Cellulose

complex carbohydrate

Also known as: wood cellulose

Citric Acid

non-nutrient/non-botanical

Also known as: acid, ácido cítrico, anhydrous citric acid, citrate, citric {acid}, citric acid, citric acid 800 mg, citric acid anhydrous, citric acid-anyhdrous, citric acid blend, citric acid cellulose, citric acid complex, citric acid crystalline, citric acid (e-330), citric acid esters, citric acid {may be used to adjust ph}, citric acid monohydrate, citric acid note: 400 mg, citric acid note: 600 mg, citric acid pdr, citric acid powder, citric acid powder, citric acid, powder, citric acid usp pharma grade powder, citricum acidum, citrus acid, natural citric acid, non-gmo citric acid, organic citric acid

Flavor

other

Flouride

mineral

Also known as: calc fluor, calcium fluoride, fluoride, sodium fluoride

Folic Acid

vitamin

Also known as: absofol, folate, folate metafolin, folatine, folic acid, l-methyltetrahydrofolate, active, metafolin, orgen fa, quatrefolic

Magnesium Malate

non-nutrient/non-botanical

Also known as: albion di-magnesium malate, albion dimagnesium malate, dimagnesium, di-magnesium di-malate, di magnesium malate, di-magnesium malate, dimagnesium malate, di-magnesium malate complex, from 1000 mg magnesium malate, from di-magnesium malate, mag. malate, magnesium, magnesium malate, magnesium malate chelate, magnesium malate complex, magnesium malate dihydrate, magnesium malate trihydrate, {mg {magnesium}} malate, traacs di-magnesium malate

Also known as: hydrated magnesium silicate, magensium silicate, magnesium silica, magnesium silicate, magnesium silicate hydroxide, magnesium silicate powder, magnesium sillicate, magnesium slicate, magnesium trisilica, magnesium trisilicate, magnesium trisillicate, natural magnesium silicate, purified talc, silicato de magnesio, talc, talc, powder, talc, purified, talcum, vegetable magnesium silicate, veg. magnesium silicate

Mannitol

non-nutrient/non-botanical

Also known as: d-mannitol, manitol, mannitol, mannitol powder, starch mannitol, synthetic mannitol

Nicotinamide

Botanical

Also known as: niacin, niacinamide, niacinamide, natural, niacin b3, niacin, granular, nicotinamide, nicotinamide riboside, nicotinamide riboside chloride, vitamin b3, natural

Also known as: pyridoxine, vitamin b6, vitamin b-6 complex

Also known as: riboflavin, riboflavin-5’-phospate sodium, riboflavin 5' phosphate, riboflavin b2, vitamin b2

Sucralose

non-nutrient/non-botanical

Also known as: and sucralose, e955, splenda(r), splenda(r) sucralose, sucralean brand sucralose, sucralean(r) brand sucralose, sucralose, sucralose powder, sucralose(r), sucralose sweetener, sucralouse, sucrase, sucrolose

Thiamin

Botanical

Also known as: thiamine, thiamine monophosphate chloride

Also known as: beta carotene, total vitamin a, vitamin a, vitamin a beadlets, vitamin a concentrate oil, vitamin a (form: fish liver oil), vitamin a usp

Also known as: 5-adenosylcobalamin, 5'-deoxyadenosylcobalamin, adenosyl b12, adenosylcobalamin, cobalamin, cobalamin concentrate, cobamamide, coenzyme b12, coenzyme vitamin b12, co-methylcobalamin, cyanocobalamin, cyanocobalamin, natural, dibencozide, hydroxocabalamin acetate, hydroxocobalamin, hydroxocobalamin acetate, hydroxocobalamin hydrochloride, hydroxycobalamin, mecobalactive, mecobalamin, methyl b12, methylcobalamin, methylcobalamin, active, methylcobalamin dicalcium phosphate, methylcobalamin, natural, methylcobalamin, pure, mixed cobalamin, mixed cobalamin, natural, nutrigenesis, poten-zyme vitamin b12, proprietary coenzyme b12, vitamin b12, vitamin b12, natural

Also known as: ascorbate palmitate, buffered vitamin c, buffered vitamin c ascorbate, calcium strontium ascorbate, l-ascorbate c crystals, vitamin c

Also known as: vitamin d, vitamin d3

Also known as: beta and delta tocotrienols, certified non-gmo mixed tocopherols, d-alpha, d-beta & d-delta tocotrienols, d-beta tocotrienol & delta tocotrienol, delta and beta tocotrienols, deltagold, delta gold 50, delta gold annatto tocotrienols, deltagold(tm) tocotrienol, deltagold tocotrienols, delta tocotrienols and beta tocotrienols, delta tocotrienols, gamma tocotrienols, d-mixed-tocotrienol, d-mixed tocotrienols, envolmax, evnol full spectrum tocotrienol complex, evnol full spectrum tocotrienol/tocopherol complex, evnol full spectrum tocotrienol/tocopherol complex, powder, evnolmax, evnolmax 20% hdt, evnol mixed tocotrienols, evnol natural full spectrum tocotrienol complex, evnol suprabio, gamma-tocotrienol, high gamma mixed tocotrienols, high-gamma mixed tocotrienols, mixed palm tocotrienol complex, mixed tocotrienol, mixed tocotrienol complex, mixed tocotrienol isomers, mixed tocotrienol oil, mixed tocotrienols, mixed tocotrienols complex, mixed tocotrienol/tocopherol oil, natural d-delta/d-beta tocotrienol, natural delta/beta tocotrienol, natural d-mixed tocotrienols, natural mixed tocotrienols, non-gmo deltagold annatto tocotrienols, oryza oil rice tocotrienol, palm tocotrienol complex, palm tocotrienols, premier tocotrienol complex, providing tocotrienols, rice bran and palm fruit oil tocotrienol complex, rice tocotrienol complex, rice tocotrienols, tocomax tocomins, tocomin suprabio, tocosource naturally mixed palm tocotrienols, tocosource palm tocotrienols, tocosource(r) naturally mixed palm tocotrienols, tocotriene complex, tocotrienol complex, tocotrienol complex, natural, tocotrienol complex tocomin, tocotrienols, tocotrienols complex, tocotrienol-tocopherol complex, total d-mixed tocotrienols, total mixed tocotrienols, total natural tocotrienols, total tocotrienols, total tocotrienols, natural, vitamin e

Xylitol

non-nutrient/non-botanical

Also known as: 100% pure xylitol, corn free xylitol, crystalline xylitol, granulated xylitol, organic xylitol, xivia, xylitol, xylitol granulation, xylitol powder, xylitol, pure

Product Statements

General Statements: All Other Content

SCI Developing Good Science into Great Medicine

Formula re: Contains

Multivitamin with Fluoride Chewable Tablets

Formulation re: Does NOT Contain

NO DYES, ARTIFICIAL FLAVORS OR SUGAR SACCHARIN AND GLUTEN FREE

Formula re: Contains

CONTAINS XYLITOL

General Statements: All Other Content

Made in U.S.A.

General Statements: All Other Content

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

General: Product/Version Code

rev. 11/18/11

Formula re: Contains

Inactive Ingredients Ingredient Name Strength Xylitol Cellulose, Microcrystalline Mannitol Talc Magnesium Stearate Talc Sucralose Citric Acid Monohydrate

General Statements: All Other Content

Product Characteristics Color WHITE (Off white to pale yellow) Score no score Shape ROUND Size 13mm Flavor FRUIT Imprint Code SCI:1 Contains

General Statements: All Other Content

Packaging # Item Code Package Description Mutlilevel Packaging 1 NDC:44945-1020-5 90 TABLET, CHEWABLE (TABLET) in 1 BOTTLE None

General Statements: All Other Content

Rx Only

General Statements: All Other Content

0.25 MG

Formula re: Contains

MVC-FLUORIDE (sodium fluoride, vitamin a, ascorbic acid, vitamin d, alpha-tocopherol, thiamine, riboflavin, niacin, pyridoxine, folic acid, and cyanocobalamin) tablet, chewable [Sancilio & Company Inc.]

General Statements: All Other Content

PRINCIPAL DISPLAY PANEL - 0.25 mg Tablet Bottle Label

Formula re: Contains

Active Ingredients/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (Fluoride Ion) Sodium Fluoride 0.25 mg Vitamin A (Vitamin A) Vitamin A 2500 [IU] Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 60 mg Vitamin D (Vitamin D) Vitamin D 400 [IU] Alpha-Tocopherol (Alpha-Tocopherol) Alpha-Tocopherol 15 [IU] Thiamine (Thiamine) Thiamine 1.05 mg Riboflavin (Riboflavin) Riboflavin 1.2 mg Niacin (Niacin) Niacin 13.5 mg Pyridoxine (Pyridoxine) Pyridoxine 1.05 mg Folic Acid (Folic Acid) Folic Acid 0.3 mg Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 4.5 mg

FDA Disclaimer Statement

NOTE: THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA.

Precautions re: All Other

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

Suggested/Recommended/Usage/Directions

Directions: USE AS DIRECTED BY YOUR PHYSICIAN.

General Statements: All Other Content

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

Precautions re: Allergies

Caution: Do not use this product if you are allergic to any of the ingredients.

Precautions re: All Other

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.

Precautions re: Children

WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

Precautions re: Children

TABLET SHOULD BE CHEWED. THIS PRODUCT, AS WITH ALL CHEWABLE TABLETS, IS NOT RECOMMENDED FOR CHILDREN UNDER AGE 4 DUE TO RISK OF CHOCKING.

General Statements: All Other Content

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.

Precautions re: Allergies

CONTAINS XYLITOL

Storage

Storage: Store in a cool, dry place at room temperature 20(0) - 25(0)C (68(0) - 77(0)F) away from heat and sunlight. Store in original container.

Precautions re: All Other

IF OVERDOSE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATLEY 1-800-222-1222

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