FLUORITAB CHEWABLE CHERRY- sodium fluoride tablet, chewable

FLUORITAB CHEWABLE by

Drug Labeling and Warnings

FLUORITAB CHEWABLE by is a Prescription medication manufactured, distributed, or labeled by Fluoritab Corporation, Medical Products Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

CONTAINS: 2.2 MG SODIUM FLUORIDE

EACH TABLET CONTAINS 1 MG FLUORIDE

DOSAGE & ADMINISTRATION

PPM FLUORIDE IONDAILY DOSAGE

IN DRINKING WATERAGE 6 MO. – 3 YRS.AGE 3-6 YRS.AGE 6-16 YRS.

LESS THAN 0.3 PPM0.25 MG 0.50 MG1 MG

0.3 TO 0.6 PPMNONE 0.25 MG 0.50 MG

OVER 0.6 PPMNONENONENONE

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

WARNINGS

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

INDICATIONS & USAGE

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

INACTIVE INGREDIENT

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

WARNINGS AND PRECAUTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLUORITAB CHEWABLE  CHERRY
sodium fluoride tablet, chewable

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0288-2203
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0288-2203-01	100 in 1 BOTTLE
2	NDC: 0288-2203-10	1000 in 1 BOTTLE
3	NDC: 0288-2203-02	5000 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	Business Operations
Medical Products Laboratories		002290302	manufacture(0288-2203)