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.

Container Label

FLUORIDE 
fluoride tablet, chewable
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 51862-172
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg
Inactive Ingredients
Ingredient NameStrength
CHERRY (UNII: BUC5I9595W)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
SACCHARIN (UNII: FST467XS7D)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize6mm
FlavorCHERRYImprint Code 172
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 51862-172-12120 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
 
Mayne Pharma Inc