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Acidul

Last reviewed on RxList: 12/8/2004
Drug Description

Acidul
(sodium fluoride) Chewable Tablets

DESCRIPTION

Sodium fluoride chewable tablets for use as a dental caries preventive in pediatric patients. Sugar-free. Saccharin-free. Each 1 mg tablet (full-strength) contains 1 mg fluoride ion (F) from 2.2 mg sodium fluoride (NaF).

Active Ingredient: Sodium Fluoride 2.2 mg.

Other Ingredients: Cherry flavor, FD&C Red #40, mannitol, magnesium stearate, and microcrystalline cellulose.

Indications & Dosage

INDICATIONS

It has been established that ingestion of fluoridated drinking water (1 ppm F) during the period of tooth development results in significant decrease in the incidence of dental caries. 1 Sodium fluoride tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from age 6 months to 16, living in areas where the drinking water fluoride level does not exceed 0.6 ppm F.

DOSAGE AND ADMINISTRATION

See schedule below to determine dosage. Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth.

AGE

0- 0.03PPM

Water F conten

0.3- 0.6 PPM

6 Mo- 3 Yrs

0.25 mg

0

3 - 6 Yrs

0.5 mg

0.25 mg

6 - 16 Yrs

1 mg

0.5 mg


 Store between 15°-30°C (59°-86°F).

Dispense in a tight, light resistant container as defined in the USP.

HOW SUPPLIED

Fluoride 1 mg* Tablets are supplied in bottles of 1000 (NDC 38245-131-20) as chewable, round, pink, unscored tablets debossed "COPLEY 131" on one side and plain on the other side.

CAUTION: Federal (U. S. A.) law prohibits dispensing without prescription.

Side Effects & Drug Interactions

SIDE EFFECTS

Allergic rash and other idiosyncrasies have been rarely reported.

DRUG INTERACTIONS

No information provided.

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Warnings & Precautions

WARNINGS

See CONTRAINDICATIONS. As in the case of all medications, keep out of reach of infants and children.

PRECAUTIONS

See OVERDOSAGE. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed.

Overdosage & Contraindications

OVERDOSE

Prolonged daily ingestion of excessive fluoride will result in varying degrees of dental fluorosis.

CONTRAINDICATIONS

Do not use in areas where the drinking water exceeds 0.3 ppm F or more. These tablets should not be administered to pediatric patients under age 6.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

Sodium fluoride acts systemically (before tooth eruption) and topically (post eruption) by increasing tooth resistance to acid dissolution, by promoting remineralization, and by inhibiting the cariogenic microbial process.

Medication Guide

PATIENT INFORMATION

See WARNINGS, CONTRAINDICATIONS and PRECAUTIONS.

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