FLUORITAB CHEWABLE CHERRY- sodium fluoride tablet, chewable 
Fluoritab Corporation

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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CONTAINS: 1.1 MG SODIUM FLUORIDE

EACH TABLET CONTAINS 0.5 MG FLUORIDE

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

CAUTION: FEDERAL (U.S.A.) LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.

DIRECTIONS: ONE TABLET PER DAY, CHEWED OR PARTIALLY DISSOLVED IN MOUTH BEFORE SWALLOWING, PREFERABLY AT NIGHT AFTER BRUSHING TEETH.

INACTIVE INGREDIENTS: LACTOSE, FLAVOR, SACCHARIN SODIUM, MAGNESIUM STEARATE

PRECAUTION -RECOMMEND DOSAGE ON CHART BELOW SHOULD NOT BE EXCEEDED AS PROLONGED OVERDOSE MAY RESULT IN DENTAL FLUOROSIS.

Fluoritab Chewable Cherry Tablets (0.5mg)_1000-ct

FLUORITAB CHEWABLE  CHERRY
sodium fluoride tablet, chewable
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0288-1106
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
LACTOSE (UNII: J2B2A4N98G)  
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize7mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0288-1106-01100 in 1 BOTTLE
2NDC:0288-1106-101000 in 1 BOTTLE
3NDC:0288-1106-025000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/09/2011
Labeler - Fluoritab Corporation (005376702)
Registrant - Fluoritab Corporation (005376702)
Establishment
NameAddressID/FEIBusiness Operations
Medical Products Laboratories002290302manufacture(0288-1106)

Revised: 10/2012
Document Id: 75d5beb2-d3d8-4e78-8df1-081095a53774
Set id: 77785440-368b-4c4f-ae52-c0384a9c3bf2
Version: 2
Effective Time: 20121029
 
Fluoritab Corporation