PreviDent 5000 Plus Fruitastic 11 mg/g

Sodium Fluoride · PASTE, DENTIFRICE · Colgate Oral Pharmaceuticals, Inc.

No Recall HistoryCurrently in Shortage

Plain English

PreviDent 5000 Plus Fruitastic is a paste, dentifrice containing sodium fluoride at 11 mg/g, taken dental. Manufactured by Colgate Oral Pharmaceuticals, Inc..

Key Facts

Brand Name: PreviDent 5000 Plus Fruitastic
Generic Name: Sodium Fluoride
NDC Code (Product): 0126-0286
Manufacturer: Colgate Oral Pharmaceuticals, Inc.
Strength: 11 mg/g
Dosage Form: PASTE, DENTIFRICE
Route: DENTAL
Marketing Status
Marketing Start: 08/29/2012

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue237 reports

nausea225 reports

pain200 reports

diarrhoea193 reports

pyrexia193 reports

weight decreased180 reports

vomiting178 reports

headache175 reports

nasopharyngitis174 reports

pneumonia173 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE A dental caries preventive, for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 PreviDent® 5000 Plus® brand of 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. This prescription dental cream should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (see WARNINGS for exception).

Dosage & Administration

DOSAGE AND ADMINISTRATION Follow these instructions unless otherwise instructed by your dental professional: Adults and pediatric patients 6 years of age or older, apply a thin ribbon of PreviDent® 5000 Plus to a toothbrush. Brush thoroughly once daily for two minutes, preferably at bedtime. After use, adults expectorate. For best results, do not eat, drink or rinse for 30 minutes. Pediatric patients, ages 6-16 years, expectorate after use and rinse mouth thoroughly.

Warnings

WARNINGS Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of dental cream which could cause dental fluorosis. Read directions carefully before using. Keep out of reach of infants and children.

Contraindications

CONTRAINDICATIONS Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

Adverse Reactions

ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have been rarely reported.

Frequently Asked Questions

What is PreviDent 5000 Plus Fruitastic used for?

PreviDent 5000 Plus Fruitastic contains Sodium Fluoride. It is a paste, dentifrice taken dental. Consult your doctor for specific uses.

Is PreviDent 5000 Plus Fruitastic a controlled substance?

PreviDent 5000 Plus Fruitastic is not classified as a controlled substance by the DEA.

What is the generic name for PreviDent 5000 Plus Fruitastic?

The generic name for PreviDent 5000 Plus Fruitastic is Sodium Fluoride. There are 12 other brand versions of Sodium Fluoride.

What is the NDC code for PreviDent 5000 Plus Fruitastic 11 mg/g?

The NDC (National Drug Code) for PreviDent 5000 Plus Fruitastic 11 mg/g is 0126-0286, listed by Colgate Oral Pharmaceuticals, Inc..

Product NDC

0126-0286

Package NDC

0126-0286-66

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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