Tri-Vitamin with Fluoride

TRI-VITAMIN WITH FLUORIDE- vitamin a, ascorbic acid, vitamin d and sodium fluoride solution/ drops
Sancilio & Company Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Ingredients

*
Each 1 mL of Tri-Vitamin Drops contains 0.25 mg Fluoride from 0.55 mg Sodium Fluoride (NaF).
Vitamin A 1500 IU
Vitamin C 35 mg
Vitamin D 400 IU
Fluoride * (as Sodium Fluoride) 0.25 mg

Other Ingredients:

Glycerin, water, polysorbate 80, sodium hydroxide, propylene glycol, sucralose, fruit flavor, methyl paraben, caramel color, propyl paraben.

Storage

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

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.

Caution

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) since these may decrease effectiveness.

Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis.

This medical food product is formulated to be administered orally, under the 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. This product is a medical food and is not intended to be used as a drug or dietary supplement.

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.

SHAKE WELL BEFORE USING

DIRECTIONS

Use as directed by a physician.

How to Use

Fill dropper to appropriate line and dispense with a single squeeze of the dropper bulb. The full dose will be given. It is normal for a small amount to remain in the tip of the dropper.

Do not accept if tamper evident box seal is broken or missing.

Manufactured by: Sancilio & Co., Inc. Riviera Beach, FL 33404 USA

PRINCIPAL DISPLAY PANEL — 50 mL Bottle Label

44946-1035-8

SCI
Sancilio &
Company, Inc.

Developing Good Science into Great Medicine

Tri -Vitamin Drops with Fluoride

VITAMINS A, C, D & FLUORIDE DROPS

NO DYES OR SUGAR
SACCHARIN AND GLUTEN FREE

0.25 mg/mL

1⅔ FL. OZ. (50 mL)

Dispense under a
physician’s order

Dietary Supplement

PRINCIPAL DISPLAY PANEL -- 50 mL Bottle Label
(click image for full-size original)
TRI-VITAMIN WITH FLUORIDE
vitamin a, ascorbic acid, vitamin d, and sodium fluoride solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44946-1035
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Vitamin A (Vitamin A) Vitamin A 1500 [iU] in 1 mL
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 35 mg in 1 mL
Vitamin D (Vitamin D) Vitamin D 400 [iU] in 1 mL
Sodium Fluoride (Fluoride Ion) Fluoride Ion 0.25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin
Water
Polysorbate 80
Sodium hydroxide
Propylene glycol
Sucralose
Methylparaben
Propylparaben
Product Characteristics
Color BROWN (Carmel) Score
Shape Size
Flavor FRUIT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44946-1035-8 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 50 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (44946-1035-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 12/20/2011 03/13/2018
Labeler — Sancilio & Company Inc (176681257)

Revised: 03/2018 Sancilio & Company Inc

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