LUDENT- sodium fluoride tablet, chewable 
Sancilio & Company Inc

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Ludent® Fluoride Chews

Each 0.5 mg Fluoride Tablet Contains:

*
Each 0.5 mg Fluoride Tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride (NaF).
Fluoride (as Sodium Fluoride)*0.5 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 "1007" 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 - 0.5 mg Bottle Label

Sancilio &
Company, Inc.

Developing Good Science into Great Medicine

44946-1009-9

Ludent®-Fluoride
Chews
Sodium Fluoride Chewable Tablets

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

0.5
mg

Dispense under a
physician's order

Dietary
Supplement

1000 tablets

PRINCIPAL DISPLAY PANEL - 0.5 mg Bottle Label
LUDENT 
sodium fluoride tablet, chewable
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:44946-1009
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.5 mg
Inactive Ingredients
Ingredient NameStrength
Xylitol (UNII: VCQ006KQ1E)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Malic Acid (UNII: 817L1N4CKP)  
Magnesium Stearate (UNII: 70097M6I30)  
Talc (UNII: 7SEV7J4R1U)  
Anhydrous Citric Acid (UNII: XF417D3PSL)  
Sucralose (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:44946-1009-324 in 1 BOX
1120 in 1 BOTTLE
2NHRIC:44946-1009-912 in 1 BOX
21000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Dietary Supplement12/20/2011
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring
shape
size (solid drugs)13 mm
imprint
flavor
Labeler - Sancilio & Company Inc (176681257)

Revised: 2/2018
Document Id: e154bf5a-e50b-4ac4-991d-8f78089f0c6f
Set id: 4a63d24a-4d80-46a5-9a8c-f8949dfc382a
Version: 4
Effective Time: 20180206
 
Sancilio & Company Inc