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Name:Renaf
Manufacturer:River's Edge Pharmaceuticals, Llc
Category:Prescription Marketed Drugs


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

RENAF   - fluoride ion and sodium fluoride tablet, chewable 
River's Edge Pharmaceuticals, LLC

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.

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

DESCRIPTION:

Each ReNaf Fluoride Chewable Tablet is sugar free
and erythrosine (FDandC 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 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.

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 5.0 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, 20-25C
(68-77F).

PACKAGING:

NDC 68032-382-12

ReNaf Fluoride Chewable Tablets 0.25 mg

(From 0.55 mg of Sodium Fluoride)

Vanilla Flavor 120 Tablets Rx Only

Active Ingredient: 0.25 mg of fluoride ion from 0.55
mg of sodium fluoride (NaF).

Inactive Ingredients: Lactose, Saccharine, Vanilla
Flavor, FDandC Yellow #6 Aluminum Lake, Magnesium
Stearate.

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

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

Manufactured for:
River’s Edge Pharmaceuticals, LLC
Suwanee, GA 30024 Iss. 02/09 382-11

ReNaf Fluoride .25mg 120ct Label

NDC 68032-383-00
ReNaf Fluoride Chewable Tablets 0.5 mg
(From 1.1 mg of Sodium Fluoride)
Grape Flavor 1000 Tablets Rx Only

Active Ingredient: 0.5 mg of fluoride ion from 1.1
mg of sodium fluoride (NaF).

Inactive Ingredients: Lactose, Saccharine, Grape
Flavor and Magnesium Stearate.

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

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

Manufactured for:
River’s Edge Pharmaceuticals, LLC
Suwanee, GA 30024 Iss. 02/09 383-11

ReNaf Fluoride .5mg 1000ct Label

NDC 68032-383-12
ReNaf Fluoride Chewable Tablets 0.5 mg
(From 1.1 mg of Sodium Fluoride)
Grape Flavor 120 Tablets Rx Only

Active Ingredient: 0.5 mg of fluoride ion from 1.1
mg of sodium fluoride (NaF).

Inactive Ingredients: Lactose, Saccharine, Grape
Flavor and Magnesium Stearate.

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

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

Manufactured for:
River’s Edge Pharmaceuticals, LLC
Suwanee, GA 30024 Iss. 02/09 383-11

ReNaf Fluoride .5mg 120ct Label

NDC 68032-384-00
ReNaf Fluoride Chewable Tablets 1.0 mg
(From 2.2 mg of Sodium Fluoride)
Cherry Flavor 1000 Tablets Rx Only

Active Ingredient: 1 mg of fluoride ion from 2.2 mg
of sodium fluoride (NaF).

Inactive Ingredients: Lactose, Saccharine, Cherry
Flavor, DandC Red #7 Calcium Lake, Magnesium
Stearate.

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

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

Manufactured for:
River’s Edge Pharmaceuticals, LLC
Suwanee, GA 30024 Iss. 02/09 384-11

ReNaf Fluoride 1.0mg 1000ct Label

NDC 68032-384-12
ReNaf Fluoride Chewable Tablets 1.0 mg
(From 2.2 mg of Sodium Fluoride)
Cherry Flavor 120 Tablets Rx Only

Active Ingredient: 1 mg of fluoride ion from 2.2
mg of sodium fluoride (NaF).

Inactive Ingredients: Lactose, Saccharine, Cherry
Flavor, DandC Red #7 Calcium Lake, Magnesium
Stearate.

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

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

Manufactured for:
River’s Edge Pharmaceuticals, LLC
Suwanee, GA 30024 Iss. 02/09 384-11

ReNaf Fluoride 1.0mg 120ct Label

RENAF  
renaf fluoride chewable tablets tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68032-382
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUORIDE ION (FLUORIDE ION) FLUORIDE ION .25 mg
SODIUM FLUORIDE (SODIUM CATION) SODIUM FLUORIDE .55 mg
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor VANILLA Imprint Code RE;382
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68032-382-12 120 TABLET, CHEWABLE ( TABLET) in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 02/27/2009

RENAF  
renaf fluoride chewable tablets tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68032-383
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUORIDE ION (FLUORIDE ION) FLUORIDE ION .5 mg
SODIUM FLUORIDE (SODIUM CATION) SODIUM FLUORIDE 1.1 mg
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor GRAPE Imprint Code RE;383
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68032-383-12 120 TABLET, CHEWABLE ( TABLET) in 1 BOTTLE None
2 NDC:68032-383-00 1000 TABLET, CHEWABLE ( TABLET) in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 02/27/2009

RENAF  
renaf fluoride chewable tablets tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68032-384
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUORIDE ION (FLUORIDE ION) FLUORIDE ION 1 mg
SODIUM FLUORIDE (SODIUM CATION) SODIUM FLUORIDE 2.2 mg
Product Characteristics
Color pink Score no score
Shape ROUND Size 6mm
Flavor CHERRY Imprint Code RE;384
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68032-384-12 120 TABLET, CHEWABLE ( TABLET) in 1 BOTTLE None
2 NDC:68032-384-00 1000 TABLET, CHEWABLE ( TABLET) in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 02/27/2009

Labeler - River's Edge Pharmaceuticals, LLC (133879135)

Revised: 11/2009 River's Edge Pharmaceuticals, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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