Otc - Active Ingredient
CONTAINS: 1.1 MG SODIUM FLUORIDE
EACH TABLET CONTAINS 0.5 MG FLUORIDE
Fluoritab Chewable
FDA Label NDC 0288-1106
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fluoritab Corporation for the product Fluoritab Chewable (NDC 0288-1106). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - keep out of reach of children, warnings, indications & usage, inactive ingredient, warnings and precautions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children
KEEP THIS AND ALL DRUGS 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.
Package Label.Principal Display Panel
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