ReNaf Fluoride Chewable Tablets

Generic Name: sodium fluoride
Dosage Form: tablet, chewable

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

ReNaf Fluoride Chewable Tablets 1.0 mg, 0.5 mg, 0.25 mg

DESCRIPTION:

Each ReNaf Fluoride Chewable Tablet is sugar free and erythrosine (FD&C Red Dye No.3) free. Each ReNaf Fluoride Chewable Tablets 1 mg contain 1 mg fluoride ion (F-) from 2.2 mg sodium fluoride (NaF). Each ReNaf Fluoride Chewable Tablets 0.5 mg contains 0.5 mg F- from 1.1 mg NaF. Each ReNaf Fluoride Chewable Tablets 0.25 mg contains 0.25mg F- from 0.55 mg NaF. 

CLINICAL PHARMACOLOGY:

Sodium fluoride acts systemically and topically by increasing tooth resistance to cavities and acid dissolution, by promoting remineralization.

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INDICATIONS AND USAGE:

ReNaf Fluoride Chewable Tablets 1.0 mg, 0.5 mg, 0.25 mg are to be used as a dental caries preventive in children. 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. ReNaf Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a once daily supplement in children from 6 months to age 3 years and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm F-.

CONTRAINDICATIONS:

ReNaf Fluoride Chewable Tablets 1.0 mg are contraindicated when the fluoride content of drinking water is 0.3 ppm F- or more and should not be administered to children under age 6 years. ReNaf Fluoride Chewable Tablets 0.5 mg are contraindicated when the fluoride content of drinking water is more than 0.6 ppm F- and should not be administered to children underage 6 when the fluoride content of drinking water is 0.3 ppm F- or more or to children under age 3 years. ReNaf Fluoride Chewable Tablets 0.25 mg are contraindicated when the fluoride content of drinking water is more than 0.6 ppm F- and should not be administered to children under age 3 years when the fluoride content of drinking water is 0.3 ppm F- or more. Do not administer any strength of ReNaf Fluoride Chewable Tablets to children under age 6 months. ReNaf Fluoride Chewable Tablets are not indicated for use in adults.

WARNINGS:

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

PRECAUTIONS:

General: Use in children below the age of 6 months is not recommended by current American Dental Association and American Academy of Pediatrics guidelines.
Drug Interactions: Do not eat or drink dairy products within one hour of fluoride administration. Using fluoride along with dairy foods is not recommended due to formation of calcium fluoride which is poorly absorbed.
Carcinogenesis, Mutagenesis, Impairment of Fertility: In animals,studies evaluating the carcinogenic potential of fluoride at greater levels than the recommended daily dose of ReNaf Fluoride Chewable Tablets are inconclusive. Fluoride ion is not mutagenic in standard bacterial systems. In vivo data are conflicting. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated.
Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Consult your physician before taking this product.
Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in human milk and caution should be exercised when ReNaf Fluoride Chewable Tablets are administered to nursing women. Consult your physician before taking this product.
Pediatric Use: The use of ReNaf Fluoride Chewable Tablets as a caries preventive in pediatric age groups 6 months to 16 years is supported by evidence from adequate and well controlled studies on fluoride supplementation from birth through adolescence.
Geriatric Use: ReNaf Fluoride Chewable Tablets are not indicated for use in geriatric patients.

ADVERSE REACTIONS:

Allergic reactions (rash, hives, itching) have rarely been reported. This is not a complete list of all the possible reactions that may occur.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

OVERDOSAGE:

If you suspect an overdosage contact your physician and/or your local Poison Control Center immediately. 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 or within 30 minutes of ingestion and are accompanied by salivation, hematemesis and epigastric cramping abdominal pain. This is not a complete list of all the symptoms that may occur with overdosage.

DOSAGE AND ADMINISTRATION:

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

HOW SUPPLIED:

ReNaf Fluoride Chewable Tablets 1.0 mg are round, pink, cherry flavored tablets in a 120-count bottle, NDC# 68032-384-12 and a 1000-count bottle, NDC# 68032-384-00.
ReNaf Fluoride Chewable Tablets 0.5 mg are round, white, grape flavored tablets in a 120-count bottle, NDC# 68032-383-12 and a 1000-count bottle, NDC# 68032-383-00.
ReNaf Fluoride Chewable Tablets 0.25 mg are round, cream colored, vanilla-flavored tablets in a 120-count bottle, NDC# 68032-382-12.

STORAGE:

Store at Controlled Room Temperature, 20-25°C (68-77°F).

PACKAGING:






RENAF FLUORIDE 
sodium fluoride tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-382
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 0.25 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE  
SACCHARIN  
FD&C YELLOW NO. 6  
MAGNESIUM STEARATE  
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor VANILLA Imprint Code RE;382
Contains         
Packaging
# Item Code Package Description
1 NDC:68032-382-12 120 TABLET, CHEWABLE (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/27/2009 12/31/2010
RENAF FLUORIDE 
sodium fluoride tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-383
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE  
SACCHARIN  
MAGNESIUM STEARATE  
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor GRAPE Imprint Code RE;383
Contains         
Packaging
# Item Code Package Description
1 NDC:68032-383-12 120 TABLET, CHEWABLE (TABLET) in 1 BOTTLE
2 NDC:68032-383-00 1000 TABLET, CHEWABLE (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/27/2009 12/31/2010
RENAF FLUORIDE 
sodium fluoride tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-384
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 1.0 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE  
SACCHARIN  
D&C RED NO. 7  
MAGNESIUM STEARATE  
Product Characteristics
Color pink Score no score
Shape ROUND Size 6mm
Flavor CHERRY Imprint Code RE;384
Contains         
Packaging
# Item Code Package Description
1 NDC:68032-384-12 120 TABLET, CHEWABLE (TABLET) in 1 BOTTLE
2 NDC:68032-384-00 1000 TABLET, CHEWABLE (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/27/2009 12/31/2010
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 11/2011
 
River's Edge Pharmaceuticals, LLC



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