Fluoride

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Fluoride Recall

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Side Effects & Adverse Reactions

Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using.

Keep out of the reach of children.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

For once daily self-applied systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water (1 ppm F*) during the period of tooth development results in a significant decrease in the incidence of dental caries. Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to 3 years of age and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm F*.

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History

There is currently no drug history available for this drug.

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Other Information

Each Fluoride Chewable Tablet 0.25 mg is erythrosine (FD&C Red Dye No.3) free. Each tablet 0.25 mg (quarter strength) contains 0.25 mg F* from 0.55 mg sodium fluoride (NaF)

Each tablet for oral administration contains sodium fluoride equivalent to fluoride 0.25 mg and the following inactive ingredients: cherry flavor, compressible sugar, croscarmellose sodium, D and C Red No. 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose.

Sources

Fluoride Manufacturers

Puretek Corporation

Fluoride | Puretek Corporation

Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth.

No Recall
Puretek Corporation

Fluoride | Puretek Corporation

Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth.

No Recall
Puretek Corporation

Fluoride | Puretek Corporation

Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth.

No Recall
Libertas Pharma, Inc.

Fluoride | Libertas Pharma, Inc.

Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth.

No Recall
Libertas Pharma, Inc.

Fluoride | Libertas Pharma, Inc.

Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth.

No Recall