Fluoride Chewable Tablets 0.5 mg

Fluoride by

Drug Labeling and Warnings

Fluoride by is a Prescription medication manufactured, distributed, or labeled by Mayne Pharma Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FLUORIDE - fluoride tablet, chewable 
Mayne 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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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.

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	Item Code (Source)	NDC: 51862-171
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.5 mg

Inactive Ingredients
Ingredient Name	Strength
GRAPE (UNII: 6X543N684K)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
SACCHARIN (UNII: FST467XS7D)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	PURPLE	Score	no score
Shape	ROUND	Size	6mm
Flavor	GRAPE	Imprint Code	171
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51862-171-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/21/2011	11/30/2018
2	NDC: 51862-171-12	120 in 1 BOTTLE; Type 0: Not a Combination Product	05/21/2011	03/31/2020

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: 7/2017

Document Id: 97c0b2dd-35e5-4fee-b068-3d9b3fbbac4d

34391-3

Set id: 0ed7502b-1888-408b-90f7-817cac125d2e

Version: 3

Effective Time: 20170726

 

Mayne Pharma Inc