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

Group: Vitamin A

Beta-Carotene is a red-orange pigment found in plants and fruits, especially carrots and colorful vegetables. It is a precursor of vitamin A and is known for its antioxidant properties, playing a crucial role in maintaining skin health and vision.

Also known as: Betatene, Vitamin A

UNII Code: 01YAE03M7J

Fluoride

mineral

Group: Flouride

UNII Code: Q80VPU408O

Folate

vitamin

Group: Vitamin B9 (Folate)

Folate, also known as Vitamin B9, is a water-soluble vitamin essential for DNA synthesis, cell growth, and the production of red blood cells. It is important for proper brain function and plays a crucial role in mental and emotional health. Folate is naturally found in a wide range of foods, including leafy green vegetables, fruits, nuts, beans, and dairy products. It is also available as a dietary supplement and is typically included in B-vitamin complexes.

Mannitol

non-nutrient/non-botanical

Group: Mannitol

UNII Code: OWL53L36A

Group: Cellulose

Microcrystalline cellulose (MCC) is a refined wood pulp that is commonly used as a texturizer, anti-caking agent, and bulking agent in food and dietary supplements. It is a white, odorless powder that is insoluble in water and is often used to improve the texture and stability of products.

Also known as: Cellulose, MCC

Group: Flavor

Niacin

vitamin

Group: Niacin

Also known as: Vitamin B3, Vit. B-3, B3, Niacinol, Nicotinic Acid, B-3, Vitamin B-3

UNII Code: 2679MF687A

Group: Vitamin B6 (pyridoxine)

Pyridoxine, commonly known as Vitamin B6, is a water-soluble vitamin that plays a critical role in brain health, production of neurotransmitters, and the metabolism of proteins, fats, and carbohydrates. It is essential for the proper functioning of sugars, fats, and proteins in the body and is crucial for the development of the brain and nervous system.

Also known as: Vitamin B6

Quali-C

vitamin

Group: Vitamin C (ascorbic acid)

Also known as: Vitamin C

Riboflavin

vitamin

Group: Vitamin B2 (Riboflavin)

Also known as: Vitamin B-2, vitamin B2, Vitamin B2, B2, activated B2, B-2, Vit. B2, pure powder B-2

UNII Code: TLM2976OFR

Sucralose

non-nutrient/non-botanical

Group: Sucralose

UNII Code: 96K6UQ3ZD4

talc

other

Group: Magnesium Silicate

Thiamine

vitamin

Group: Thiamin

Also known as: Vitamin B1, B1, Vitamin B-1, B-1

UNII Code: X66NSO3N35

Vitamin A

vitamin

Group: Vitamin A

Also known as: Betatene(R), Betatene, CaroCare, Caromin(R)

UNII Code: 81G40H8B0T

Vitamin B1

vitamin

Group: Vitamin B1 (unspecified)

Vitamin B1, also known as Thiamine, is a water-soluble vitamin that is crucial for energy metabolism and plays a significant role in the functioning of nerves, muscles, and the heart.

Also known as: Thiamine

Group: Vitamin B12

UNII Code: 8406EY2OQA

Vitamin B2

vitamin

Group: Vitamin B2 (unspecified)

Vitamin B2, also known as Riboflavin, is a vital nutrient that belongs to the vitamin B complex. It plays a crucial role in energy production and the metabolism of fats, drugs, and steroids. Riboflavin is found in foods like eggs, green vegetables, milk, and meat, as well as in fortified foods and supplements.

Also known as: Riboflavin

Group: Folate

Vitamin B9, commonly known as folic acid or folate, is a B-vitamin essential for various bodily functions, including DNA synthesis and repair, cell division, and growth. It is particularly important during periods of rapid growth such as during pregnancy and fetal development. Folic acid is the synthetic form often used in supplements and fortified foods, while folate is the naturally occurring form found in certain foods.

Also known as: Folic Acid, Folate

UNII Code: 935E97BOY8

Vitamin D

Vitamin

Group: Vitamin D

Vitamin D is a fat-soluble vitamin that is essential for maintaining the health of bones and teeth, supporting the immune system, and regulating insulin levels. It is also important for brain health and has been linked to mood regulation.

Also known as: Cholecalciferol, Ergocalciferol, Vitamin D2, Vitamin D3

UNII Code: 7K5B0E8I9D

Xylitol

non-nutrient/non-botanical

Group: Xylitol

UNII Code: VCQ006KQ1E

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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