Ludent Fluoride Chews

Dosage Form: tablet, chewable
Ludent® Fluoride Chews

Each 1.0 mg Fluoride Tablet Contains:

* Each 1.0 mg Fluoride Tablet contains 1.0 mg Fluoride from 2.2 mg Sodium Fluoride (NaF).
Fluoride (as Sodium Fluoride)*	1.0 mg

Warning

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. TABLET SHOULD BE CHEWED. THIS PRODUCT, AS WITH ALL CHEWABLE TABLETS, IS NOT RECOMMENDED FOR CHILDREN UNDER AGE 4 DUE TO RISK OF CHOKING.

DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING

Directions

USE AS DIRECTED BY YOUR PHYSICIAN.

Description

White to off-white, orange flavor, round-shaped chewable tablet debossed "SCI" on one side and "4" on the other.

See inside panel for additional information

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). Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis. Account for all daily sources of fluoride intake.

Other Ingredients

Xylitol, microcrystalline cellulose, malic acid, magnesium stearate, talc, citric acid, natural orange flavor, sucralose.

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.

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.

Manufactured by: Sancilio & Co., Inc.

Riviera Beach, FL 33404 USA

rev. 12/02/11

PRINCIPAL DISPLAY PANEL - 1.0 mg Bottle Label

SCI

Sancilio &

Company, Inc.

Developing Good Science into Great Medicine

44946-1010-3

Rx Only

Ludent®-Fluoride

Chews

Sodium Fluoride Chewable Tablets

NO DYES, ARTIFICIAL FLAVORS OR SUGAR

SACCHARIN AND GLUTEN FREE

CONTAINS XYLITOL

1.0

mg*

120 tablets

Made in U.S.A.

LUDENT  sodium fluoride  tablet, chewable

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 44946-1010 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (Fluoride Ion) Sodium Fluoride 1 mg

Inactive Ingredients Ingredient Name Strength Xylitol   Cellulose, Microcrystalline   Malic Acid   Magnesium Stearate   Talc   Anhydrous Citric Acid   Sucralose

Product Characteristics Color WHITE (White to off white) Score score with uneven pieces Shape ROUND Size 13mm Flavor ORANGE Imprint Code SCI;4 Contains

Packaging # NDC Package Description Multilevel Packaging 1 44946-1010-3 24 BOTTLE In 1 BOX contains a BOTTLE 1 120 TABLET In 1 BOTTLE This package is contained within the BOX (44946-1010-3)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		12/20/2011

Labeler - Sancilio & Company Inc (176681257)

Revised: 12/2011Sancilio & Company Inc