Medication Guide App

Sodium Fluoride Chewable Tablets

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.

Fluoride Chewable Tablets 0.5 mg

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.

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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.

FLUORIDE 
fluoride tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51862-171
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.5 mg
Inactive Ingredients
Ingredient Name Strength
GRAPE  
LACTOSE  
SACCHARIN  
MAGNESIUM STEARATE  
Product Characteristics
Color PURPLE Score no score
Shape ROUND Size 6mm
Flavor GRAPE Imprint Code 171
Contains         
Packaging
# Item Code Package Description
1 NDC:51862-171-10 1000 TABLET, CHEWABLE (TABLET) in 1 BOTTLE
2 NDC:51862-171-12 120 TABLET, CHEWABLE (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/21/2011
Labeler - Libertas Pharma, Inc. (962128943)
Revised: 08/2012
 
Libertas Pharma, Inc.



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