Your browser does not support JavaScript! FLUORIDE TABLET, CHEWABLE [LIBERTAS PHARMA, INC.]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

FLUORIDE tablet, chewable
[Libertas Pharma, Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

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.

Container Label

FLUORIDE 
fluoride tablet, chewable
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:51862-171
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.5 mg
Inactive Ingredients
Ingredient NameStrength
GRAPE 
LACTOSE 
SACCHARIN 
MAGNESIUM STEARATE 
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize6mm
FlavorGRAPEImprint Code 171
Contains    
Packaging
#Item CodePackage Description
1NDC:51862-171-101000 in 1 BOTTLE
2NDC:51862-171-12120 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other05/21/2011
Labeler - Libertas Pharma, Inc. (962128943)

Revised: 08/2012
Document Id: 79416bf8-bc96-4c9c-8be8-65c0357252bd
Set id: 0ed7502b-1888-408b-90f7-817cac125d2e
Version: 2
Effective Time: 20120814
 
Libertas Pharma, Inc.

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services