Your browser does not support JavaScript! LUDENT (SODIUM FLUORIDE) TABLET, CHEWABLE [SANCILIO & COMPANY INC.]
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RxNorm Names

LUDENT (sodium fluoride) tablet, chewable
[Sancilio & Company Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

Each 0.25 mg Fluoride Tablet Contains:

*
Each 0.25 mg Fluoride Tablet contains 0.25 mg Fluoride from 0.55 mg Sodium Fluoride (NaF).
Fluoride (as Sodium Fluoride)*0.25 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 "6" 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 - .25 mg Bottle Label

SCI
Sancilio &
Company, Inc.

Developing Good Science into Great Medicine

44946-1008-3
Rx Only

Ludent®-Fluoride
Chews

Sodium Fluoride Chewable Tablets

NO DYES, ARTIFICIAL FLAVORS OR SUGAR
SACCHARIN AND GLUTEN FREE
CONTAINS XYLITOL

0.25
mg*

120 tablets

Made in U.S.A.

PRINCIPAL DISPLAY PANEL - .25 mg Bottle Label
LUDENT 
sodium fluoride tablet, chewable
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:44946-1008
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Sodium Fluoride0.25 mg
Inactive Ingredients
Ingredient NameStrength
Xylitol 
Cellulose, Microcrystalline 
Malic Acid 
Magnesium Stearate 
Talc 
ANHYDROUS CITRIC ACID 
Sucralose 
Product Characteristics
ColorWHITE (White to off white) Scorescore with uneven pieces
ShapeROUNDSize11mm
FlavorORANGEImprint Code SCI;6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44946-1008-324 in 1 BOX
1120 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER12/20/2011
Labeler - Sancilio & Company Inc. (176681257)

Revised: 12/2011
 
Sancilio & Company Inc.

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