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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.

Active Ingredient: 1 mg of fluoride ion from 2.2 mg of sodium fluoride (NaF).

Inactive Ingredients: Lactose, Saccharine, Cherry Flavor, D&C Red #7 Calcium Lake, 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)

743634

Manufactured for:
Libertas Pharma, Inc.
Lawrenceville, GA 30043
Iss. 03/11   172-12

Container Label

NDC 51862-172-12

Fluoride Chewable Tablets

1 mg

(From 2.2 mg of Sodium Fluoride)

Cherry Flavor       120 Tablets       Rx Only

Libertas
Pharma Inc.

FLUORIDE 
fluoride tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51862-172
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1 mg
Inactive Ingredients
Ingredient Name Strength
CHERRY  
LACTOSE, UNSPECIFIED FORM  
SACCHARIN  
D&C RED NO. 7  
MAGNESIUM STEARATE  
Product Characteristics
Color RED Score no score
Shape ROUND Size 6mm
Flavor CHERRY Imprint Code 172
Contains     
Packaging
# Item Code Package Description
1 NDC:51862-172-12 120 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/21/2011 03/31/2020
Labeler - Mayne Pharma Inc (867220261)
Revised: 07/2017
 
Mayne Pharma Inc
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