Sodium Fluoride Chewable Tablets

Fluoride Chewable Tablets 1 mg

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 NDC Product Code (Source) 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   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 # NDC Package Description Multilevel Packaging 1 51862-172-12 120 TABLET In 1 BOTTLE None

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: 05/2011Libertas Pharma, Inc.