Fluoritab Chewable
FDA Label NDC 0288-2203

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 0288-2203). 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, dosage & administration, 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 - 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

Otc - 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.

Package Label.Principal Display Panel

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