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Ludent Fluoride Chews

Generic Name: sodium fluoride
Dosage Form: tablet, chewable

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.

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 LABEL Item Code (Source) NDC: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
# Item Code Package Description
1 NDC:44946-1010-3 24 BOTTLE (BOTTLE) in 1 BOX
1 120 TABLET, CHEWABLE (TABLET) in 1 BOTTLE
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: 12/2011
 
Sancilio & Company Inc



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