FLUORITAB CHEWABLE CHERRY

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.

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 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 Multilevel Packaging 1 NDC:0288-1106-01 100 TABLET, CHEWABLE in 1 BOTTLE None 2 NDC:0288-1106-10 1000 TABLET, CHEWABLE in 1 BOTTLE None 3 NDC:0288-1106-02 5000 TABLET, CHEWABLE in 1 BOTTLE None

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