Sodium Fluoride drug information

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 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.

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 Method Pharmaceuticals, LLC at 877-250-3427. Store at controlled room temperature 15° to 30°C (59° to 86°F).

SODIUM FLUORIDE- sodium fluoride solution/ drops S odium Fluoride Drops 0.5 mg/mL GRAPE FLAVORED Dosages 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).

Description 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. Sugar Free, Alcohol Free, Dye Free and Gluten Free. Supplement Facts Serving Size: 1 mL Servings Per Container: 50 Amount per serving % Daily Value Fluoride (as Sodium Fluoride) 0.5 mg ** ** Daily Value not established. Active Ingredients: Sodium Fluoride (0.11% w/v). Other Ingredients: Glycerin, methylparaben, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose. FLUORIDE SUPPLEMENT DOSAGE SCHEDULES 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) None None 3 to 6 years One dropperful 0.5 mg F (1 mL)† Half dropperful 0.25 mg F (1/2 mL) None 6 to 16 years Two dropperfuls 1 mg F (2 mL) One dropperful 0.5 mg F (1 mL) None * 1.0 ppm = 1 mg/Liter † 1.1 mg Sodium Fluoride contains 0.5 mg Fluoride ion 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. Table text from source: | FLUORIDE SUPPLEMENT DOSAGE SCHEDULES | 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) | None | None | 3 to 6 years | One dropperful 0.5 mg F (1 mL)† | Half dropperful 0.25 mg F (1/2 mL) | None | 6 to 16 years | Two dropperfuls 1 mg F (2 mL) | One dropperful 0.5 mg F (1 mL) | None

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.

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 use in the eyes.

Overdosage 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.

How Supplied 50 mL bottles (58657-322-50)

References 1. Accepted Dental Therapeutics, Ed. 40. American Dental Association, Chicago, 1984:399-402. 2. Jakush, J, New Fluoride Schedule Adopted. ADA News. May 16, 1994:12-14. Manufactured by: Method Pharmaceuticals, LLC Fort Worth, TX 76118 Rev. 07/2018 dropper