Prevident 5000 Dry Mouth Drug Information

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 Dry Mouth brand of 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste 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.)

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 Dry Mouth to a toothbrush. Brush thoroughly once daily for two minutes, preferably at bedtime, in place of your regular toothpaste. 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.

Allergic reactions and other idiosyncrasies have been rarely reported.

Please refer to the CONTRAINDICATIONS and WARNINGS sections.

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

Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours.

If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.

A treatment dose (a thin ribbon) of PreviDent ® 5000 Dry Mouth contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately 610 mg fluoride.