Fluoride Chewable Tablets 1 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 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	Item Code (Source)	NDC: 51862-172
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1 mg

Inactive Ingredients
Ingredient Name	Strength
CHERRY (UNII: BUC5I9595W)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
SACCHARIN (UNII: FST467XS7D)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	6mm
Flavor	CHERRY	Imprint Code	172
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51862-172-12	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: 28d952e7-7caa-492f-a1f5-7a39098da55e

34391-3

Set id: 00e1f644-1538-4054-b112-227e7254317e

Version: 2

Effective Time: 20170726

 

Mayne Pharma Inc