FULL PRESCRIBING INFORMATION: CONTENTS*
- Clinical Pharmacology
- Indications and Usage
- Side Effects
- TAMPER EVIDENT
- How Supplied
- PRINCIPAL DISPLAY PANEL - 0.5 mg Bottle Carton
FULL PRESCRIBING INFORMATION
Each mL of Sodium Fluoride Drops contains 0.5 mg Fluoride ion (F) from 1.1 mg Sodium Fluoride (NaF). For use as a dental caries preventive in pediatric patients. No dyes, artificial flavors or sugar. Saccharin free. Gluten free.
Active Ingredients: Sodium Fluoride (0.11% w/v).
Other Ingredients: Glycerin, purified water, xylitol, propylene glycol, natural grape flavor, sucralose, methyl paraben, propyl paraben.
|AGE||Fluoride Ion Level in Drinking Water (ppm)
|< 0.3 ppm||0.3 - 0.6 ppm||> 0.6 ppm|
|Birth to 6 months||None||None||None|
|6 months to 3 years||Half dropperful
0.25 mg F (1/2 mL)
|3 to 6 years||One dropperful
0.5 mg F (1 mL)
0.25 mg F (1/2 mL)
|6 to 16 years||Two dropperfuls
1 mg F (2 mL)
0.5 mg F (1 mL)
Fluoride Supplement Dose Schedule approved by the American Dental Association, American Academy of Pediatrics and American Academy of Pediatric Dentistry.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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
As a supplemental source of Fluoride. 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.1 Sodium Fluoride Drops 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.
Do not use in areas where drinking water exceeds 0.6 ppm F. Do not administer to pediatric patients less than 6 months old.
Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using. Keep out of the reach of infants and children.
See "Overdosage" section. Incompatibility of Fluoride with dairy foods has been reported due to formation of Calcium Fluoride which is poorly absorbed. Not for use in the eyes.
Allergic rash and other idiosyncrasies have been rarely reported.
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or Sancilio & Company, Inc. at 1-800-SCI-0513.
Store at controlled room temperature 15° to 30°C (59° to 86°F).
Do not accept if printed bottle seal around cap is broken or missing.
Prolonged daily ingestion of excessive Fluoride may result in varying degrees of dental fluorosis. The total amount of Sodium Fluoride in a bottle of 50 mL (0.5 mg/mL) Sodium Fluoride Drops (25 mg F) conforms with the recommendations of the American Dental Association for the maximum to be dispensed at one time for safety purposes. If overdose is suspected, call 1-800-222-1222 (American Association of Poison Control Centers), your local poison control center (www.aapcc.org), or emergency room immediately for treatment recommendations.
Dosage§ and Administration
Daily oral dose: (in areas where the drinking water contains less than 0.3 ppm F) age 6 months to 3 years: one half dropperful (1/2 mL); age 3 to 6 years, one dropperful (1 mL); age 6 to 16 years, two dropperfuls (2 mL). When drinking water is partially fluoridated (0.3 to 0.6 ppm F inclusive) dose as follows: age 6 months to 3 years, Fluoride supplementation not indicated; age 3 to 6 years, one half dropperful (1/2 mL); age 6 to 16 years, one dropperful (1 mL).
50 mL bottles (44946-1032-8)
- Accepted Dental Therapeutics, Ed. 40. American Dental Association, Chicago, 1984:399-402.
- Jakush, J, New Fluoride Schedule Adopted. ADA News. May 16, 1994:12-14.
Manufactured by: Sancilio & Company, Inc.
3874 Fiscal Court #200
Riviera Beach, FL 33404
PRINCIPAL DISPLAY PANEL - 0.5 mg Bottle Carton
Sancilio & Company, Inc.
Developing Good Science into Great Medicine
NO DYES, ARTIFICIAL FLAVORS OR SUGAR
1⅔ FL. OZ. (50 mL)
Made in the U.S.A.
Sodium Fluoride SOLUTION/ DROPS