Your browser does not support JavaScript! FLUORITAB CHEWABLE CHERRY (SODIUM FLUORIDE) TABLET, CHEWABLE [FLUORITAB CORPORATION]
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FLUORITAB CHEWABLE CHERRY (sodium fluoride) tablet, chewable
[Fluoritab Corporation]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

CONTAINS: 2.2 MG SODIUM FLUORIDE

EACH TABLET CONTAINS 1 MG FLUORIDE

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.

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 (1mg)_1000-ct

FLUORITAB CHEWABLE  CHERRY
sodium fluoride tablet, chewable
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0288-2203
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE 
SACCHARIN SODIUM ANHYDROUS 
MAGNESIUM STEARATE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize7mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0288-2203-01100 in 1 BOTTLE
2NDC:0288-2203-101000 in 1 BOTTLE
3NDC:0288-2203-025000 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(0288-2203)

Revised: 10/2012
Document Id: 2448eb27-df71-4bb1-814a-4766458a9505
Set id: cd18915a-0b63-4fed-aebe-0c2fe60d8505
Version: 2
Effective Time: 20121029
 
Fluoritab Corporation

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