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Name:Sodium Fluoride
Manufacturer:Libertas Pharma, Inc.
Category:Prescription Marketed Drugs


Sodium Fluoride Drops 0.5 mg Drops Peach Flavored

SODIUM FLUORIDE - sodium fluoride solution/ drops 
Libertas Pharma, Inc.

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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Sodium Fluoride Drops 0.5 mg Drops Peach Flavored

* Conforms to new ADA and AAP guidelines for supplementation.

DOSAGE SCHEDULE * WATER F CONTENT
 AGE 0- 0.3 PPM 0.3-0.6 PPM > 0.6 PPM
6 months to 3 years 0.25 mg F = 1/2 mL = Half dropperful 0 0
3-6 years 0.5 mg F= 1 mL = One dropperful 0.25 mg F= 1/2 mL = Half dropperful 0
6-16 years 1 mg F= 2 mL = Two dropperfuls 0.5 mg F= 1 mL = One dropperful 0

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.

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.

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.

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.

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.

Container Label


SODIUM FLUORIDE 
sodium fluoride solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51862-165
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
METHYLPARABEN  
PEACH  
WATER  
D&C RED NO. 33  
SODIUM BENZOATE  
SUCRALOSE  
FD&C YELLOW NO. 6  
Product Characteristics
Color ORANGE (peach) Score     
Shape Size
Flavor PEACH Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51862-165-50 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 50 mL in 1 BOTTLE This package is contained within the CARTON (51862-165-50)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/21/2011

Labeler - Libertas Pharma, Inc. (962128943)

Revised: 05/2011 Libertas Pharma, Inc.



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


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