Sodium Fluoride

Libertas Pharma, Inc.

Sodium Fluoride Drops 0.5 mg Drops Peach Flavored

FULL PRESCRIBING INFORMATION: CONTENTS*

• SODIUM FLUORIDE DESCRIPTION
• CLINICAL PHARMACOLOGY
• SODIUM FLUORIDE INDICATIONS AND USAGE
• SODIUM FLUORIDE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• SODIUM FLUORIDE ADVERSE REACTIONS
• OVERDOSAGE
• SODIUM FLUORIDE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
  • *REFERENCES
  • RECOMMENDED STORAGE:
• Container Label

FULL PRESCRIBING INFORMATION

* Conforms to new ADA and AAP guidelines for supplementation.

SODIUM FLUORIDE DESCRIPTION

Each mL of Sodium Fluoride Drops 0.5 mg contains 0.5 mg fluoride ion (F-) from 1.1 mg sodium fluoride (NaF). For use as a dental caries preventive in pediatric patients. Sugar-free and saccharin-free.

Active Ingredients: Sodium Fluoride 0.11% (w/v).
Other Ingredients: Citric acid, methyl paraben, peach flavor, purified water, red #33, sodium benzoate, sucralose, yellow #6.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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.

SODIUM FLUORIDE INDICATIONS AND USAGE

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. Sodium Fluoride Drops 0.5 mg were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to age 3 and older, living in areas where the drinking water fluoride level does not exceed 0.6 ppm F.

SODIUM FLUORIDE CONTRAINDICATIONS

Do not use in areas where drinking water exceeds 0.6 ppm F. Do not administer to pediatric patients less than 6 months old.

WARNINGS

(See "CONTRAINDICATIONS" above.

PRECAUTIONS

See “ "OVERDOSAGE" ” section. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed. Not for ophthalmic use.

SODIUM FLUORIDE ADVERSE REACTIONS

Allergic rash and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Prolonged daily ingestion of excessive fluoride will result in varying degrees of dental fluorosis. For safety purposes, the total amount of sodium fluoride in a 50 mL bottle of Sodium Fluoride Drops 0.5 mg (25 mg F) conforms with the recommendations of the American Dental Association for the maximum to be dispensed at one time.

SODIUM FLUORIDE DOSAGE AND ADMINISTRATION

Daily oral dose: (in areas where the drinking water contains less than 0.3 ppm F): 6 months to age 3: one half dropperful (1/2 mL); age 3-6, one dropperful (1 mL); age 6-16, two dropperfuls (2 mL). When drinking water is partially fluoridated (0.3 to 0.6 ppm F inclusive) dose as follows: 6 months to age 3, fluoride supplementation not indicated; age 3-6, one half dropperful (1/2 mL); age 6-16, one dropperful (1 mL)*

* Conforms to new ADA and AAP guidelines for supplementation.

HOW SUPPLIED

Sodium Fluoride Drops 0.5 mg is supplied in 50 mL bottles with calibrated dropper,
NDC 51862-165-50.

TAMPER EVIDENT: Do not accept if printed bottle seal around cap is broken or missing.

*REFERENCES

Accepted Dental Therapeutics, Ed. 40. American Dental Association, Chicago, 1984, p.339-402. Jakush, J, New Fluoride schedule adopted. ADA News, May 16, 1994, p.12,14.

RECOMMENDED STORAGE:

Store at controlled room temperature 15˚ to 30˚ C (59˚ to 86˚ F).

Manufactured for:
Libertas Pharma, Inc.
Lawrenceville, GA 30043

Iss. 03/11 165-50         743631

Container Label

NDC 51862-165-50

Rx Only

Sodium Fluoride Drops

0.5 mg Drops

Peach Flavored

SUGAR and SACCHARIN FREE

For Children and Adults

1 2/3 fl. oz. (50 mL)

Libertas
Pharma Inc.