Sodium Fluoride Drops

Name: Sodium Fluoride Drops

Uses of Sodium Fluoride Drops

  • This supplement is used to prevent cavities.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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.

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.

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.

SODIUM FLUORIDE 
sodium fluoride solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL 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
1 NDC:51862-165-50 1 BOTTLE in 1 CARTON
1 50 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/21/2011 09/30/2019
Labeler - Mayne Pharma Inc (867220261)
Revised: 07/2017   Mayne Pharma Inc
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