Data from FDA - Curated by EPG Health - Last updated 25 January 2018

Indication(s)

INDICATIONS AND USAGE: For once daily, self-administered, systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water ( 1 ppm F ) during the period of tooth development results in a significant decrease in the incidence of dental caries. Kirkman's 2.21 mg Sodium Fluoride Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients form 6 months to 16 years of age living in areas where the drinking water fluoride content does not exceed 0.6 ppm (F).

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Advisory information

contraindications
CONTRAINDICATIONS: Krikman's 2.21 mg Sodium Fluoride Tablets, are contraindicated when the fluoride content of drinking water is 0.6 ppm (F) or more and should not be administered to pediatric patients under the age of 6 months. Do not administer fluoride (any strength) to pediatric patients under age 6 months.
Special warnings and precautions
PRECAUTIONS: General: Please refer to CONTRAINDICATIONS, WARNINGS, and OVERDOSAGE sections for overdose concerns. Use in pediatric patients below the age of 6 months is not recommended by current American Dental Association and American Academy of Pediatrics guidelines.
Adverse reactions
ADVERSE REACTIONS: Allergic rash and other idiosyncrasies have rarely been reported. Call your doctor for medical advice about side effects. You may report side effects tot the FDA at 1-800-FDA-1088.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION: Follow the direction for using this medication provided by your doctor. Daily Pediatric Dose: Fluoride Content of Drinking Water: Birth to 6 mos. 6 mos. to Age 3 Age 3 to 6 Age 6 to 16 Less than 0.3 ppm 0 1/4 tablet 1/2 tablet 1 tablets 0.3 to 0.6 ppm 0 0 1/4 tablet 1/2 tablet Greater than 0.6 ppm 0 0 0 0
Pregnancy and lactation
Nursing Mothers: It is not known if fluoride ion is excreted in human milk. However, many drugs are excreted in human milk and caution should be exercised when Kirkman's 2.21 mg Sodium Tablets are administered to nursing women.

Interactions

Drug Interactions: Do not eat or drink dairy products within one hour of fluoride administration. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed.

More information

Category Value
Agency product number 8ZYQ1474W7
Orphan designation No
Product NDC 58223-679
Date Last Revised 21-12-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 315213
Storage and handling STORAGE AND HANDLING Store at Controlled Room Temperature, 20-25 °C (68-77 °F). See USP "Controlled Room" for further information. NDC 58223-679-01 Manufactured for KIRKMAN Laboratories, Inc 17387 SW 63rd Ave. Lake Oswego, OR 97035
Marketing authorisation holder KIRKMAN GROUP, INC.