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.

Container Label

FLUORIDE 
fluoride tablet, chewable
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51862-171
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg
Inactive Ingredients
Ingredient NameStrength
GRAPE (UNII: 6X543N684K)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
SACCHARIN (UNII: FST467XS7D)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize6mm
FlavorGRAPEImprint Code 171
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51862-171-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/21/201111/30/2018
2NDC:51862-171-12120 in 1 BOTTLE; Type 0: Not a Combination Product05/21/201103/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other05/21/201103/31/2020
Labeler - Mayne Pharma Inc (867220261)

Revised: 7/2017
Document Id: 97c0b2dd-35e5-4fee-b068-3d9b3fbbac4d
Set id: 0ed7502b-1888-408b-90f7-817cac125d2e
Version: 3
Effective Time: 20170726
 
Mayne Pharma Inc