Acidul

What is Acidul and how is it used?

Acidul is a prescription medicine used to treat symptoms of Dental Caries Prevention. Acidul may be used alone or with other medications.

Acidul belongs to a class of drugs called Minerals, Other.

It is not known if Acidul is safe and effective in children younger than 6 months of age.

What are the possible side effects of Acidul?

Acidul may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• very upset stomach,
• nausea,
• vomiting, and
• staining, pitting, or any other change in the appears of your teeth

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Acidul include:

• none

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Acidul. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

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

Allergic rash and other idiosyncrasies have been rarely reported.

DRUG INTERACTIONS

No information provided.

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.

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

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.

PATIENT INFORMATION

See WARNINGS, CONTRAINDICATIONS and PRECAUTIONS.