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Fluoritab Chewable

Generic Name: sodium fluoride
Dosage Form: tablet, chewable

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.

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
sodium fluoride tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0288-1106
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE  
SACCHARIN SODIUM ANHYDROUS  
MAGNESIUM STEARATE  
Product Characteristics
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:0288-1106-01 100 TABLET, CHEWABLE in 1 BOTTLE
2 NDC:0288-1106-10 1000 TABLET, CHEWABLE in 1 BOTTLE
3 NDC:0288-1106-02 5000 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/09/2011
Labeler - Fluoritab Corporation (005376702)
Registrant - Fluoritab Corporation (005376702)
Establishment
Name Address ID/FEI Operations
Medical Products Laboratories 002290302 manufacture(0288-1106)
Revised: 10/2012
 
Fluoritab Corporation



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