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Fluoride

Libertas Pharma, Inc.

Fluoride Chewable Tablets 0.5 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

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

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

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 0.5 mg

Inactive Ingredients

Ingredient Name Strength
GRAPE
LACTOSE
SACCHARIN
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
PURPLE 6 mm 171 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51862-171-10 1000 in 1 BOTTLE
2 NDC:51862-171-12 120 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-05-21


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