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]

HEALTH CLAIM

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.

STATEMENT OF IDENTITY

Ingredients

* Each 1 mL of Tri-Vitamin Drops contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride (NaF).
Vitamin A	1500 IU
Vitamin C	35 mg
Vitamin D	400 IU
Fluoride* (as Sodium Fluoride)	0.5 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.

HEALTH CLAIM

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

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

44946-1036-8

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

0.5
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:44946-1036
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	0.5 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:44946-1036-8	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)