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

Tri-Vitamin with Fluoride by

Drug Labeling and Warnings

Tri-Vitamin with Fluoride by is a Other medication manufactured, distributed, or labeled by Sancilio & Company Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

HEALTH CLAIM

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:44946-1035
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T)	Vitamin A	1500 [iU]  in 1 mL
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	35 mg  in 1 mL
Vitamin D (UNII: 9VU1KI44GP) (Vitamin D - UNII:9VU1KI44GP)	Vitamin D	400 [iU]  in 1 mL
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	0.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Sodium hydroxide (UNII: 55X04QC32I)
Propylene glycol (UNII: 6DC9Q167V3)
Sucralose (UNII: 96K6UQ3ZD4)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:44946-1035-8	1 in 1 CARTON
1		50 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement		12/20/2011

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
flavor

Labeler - Sancilio & Company Inc (176681257)