Tri-Vitamin with Fluoride description, usages, side effects, indications, overdosage, supplying and lots more!

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Tri-Vitamin with Fluoride

Sancilio & Company Inc

Tri-Vitamin Drops with Fluoride


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Ingredients

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

44946-1035-8
Rx Only

Sancilio & Company, Inc.
Developing Good Science into Great Medicine

Tri-Vitamin Drops
with Fluoride

VITAMINS A, C, D
AND FLUORIDE DROPS

0.25
mg/mL*

NO DYES OR SUGAR
SACCHARIN AND GLUTEN FREE

*Each 1 mL of Tri-Vitamin Drops
provides 0.25 mg Fluoride

1⅔ FL. OZ. (50 mL)

Made in U.S.A.

Tri-Vitamin with Fluoride

Tri-Vitamin with Fluoride

Vitamin A, Ascorbic Acid, Vitamin D, and Sodium Fluoride SOLUTION/ DROPS

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:44946-1035
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
VITAMIN A 1500 [iU]
ASCORBIC ACID ASCORBIC ACID 35 mg
Vitamin D 400 [iU]
SODIUM FLUORIDE FLUORIDE ION 0.25 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
water
polysorbate 80
SODIUM HYDROXIDE
propylene glycol
Sucralose
METHYLPARABEN
PROPYLPARABEN

Product Characteristics

Color
BROWN (Carmel)

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-12-20


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Be sure to consult your doctor before taking any medication!
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