FLUORIDE  - sodium fluoride tablet, chewable 
Libertas Pharma, Inc.

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.

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Active Ingredient: 0.5 mg of fluoride ion from 1.1 mg of sodium fluoride (NaF).

Inactive Ingredients: Lactose, Saccharine, Grape Flavor and Magnesium Stearate.

DOSAGE AND ADMINISTRATION:

Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth.

STORAGE:

Store at a Controlled Room Temperature 20º-25ºC (68º-77ºF)

743633

Manufactured for:
Libertas Pharma, Inc.
Lawrenceville, GA 30043
Iss. 03/11   171-10

Container Label

NDC 51862-171-10

Fluoride Chewable Tablets

0.5 mg

(From 1.1 mg of Sodium Fluoride)

Grape Flavor       1000 Tablets       Rx Only

Libertas
Pharma Inc.

Container Label


FLUORIDE 
fluoride tablet, chewable
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51862-171
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.5 mg
Inactive Ingredients
Ingredient NameStrength
GRAPE 
LACTOSE 
SACCHARIN 
MAGNESIUM STEARATE 
Product Characteristics
ColorPURPLEScore no score
ShapeROUNDSize6mm
FlavorGRAPEImprint Code 171
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:51862-171-101000 TABLET, CHEWABLE ( TABLET) in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other05/21/2011

Labeler - Libertas Pharma, Inc. (962128943)

Revised: 05/2011 Libertas Pharma, Inc.