{"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."],"clinical_pharmacology":["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."],"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."],"description":["DESCRIPTION: Kirkman's 2.21 mg (1.0 mg fluoride ion) Sodium Fluoride Tablets are dye free. Each 2.21 mg (full strength) tablet contains 1.0 mg of the fluoride ion (F) from 2.21 mg sodium fluoride (NaF). Each tablet for oral administration contain sodium fluoride equivalent to 1.0 mg of the fluoride ion and the following inactive ingredients: Lactose, Cherry Flavor, Saccharin Sodium and Magnesium Stearate."],"dosage_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"],"dosage_and_administration_table":["
Daily Pediatric Dose:
Fluoride Content of Drinking Water:Birth to 6 mos.6 mos. to Age 3Age 3 to 6Age 6 to 16
Less than 0.3 ppm01/4 tablet1/2 tablet1 tablets
0.3 to 0.6 ppm001/4 tablet1/2 tablet
Greater than 0.6 ppm0000
"],"drug_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."],"effective_time":"20201207","geriatric_use":["Geriatric Use: Not indicated for use in geriatric patients."],"id":"f709b5f8-7cec-448d-bf1f-5afd94aa634a","indications_and_usage":["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)."],"nursing_mothers":["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."],"openfda":{},"overdosage":["OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for up to 24 hours. If less than 5 mg sodium fluoride/kg body weight (i.e. less than 2.3 mg sodium fluoride/lb body weight) has been ingested, induce vomiting, give orally soluble calcium (e.g. milk, 5% calcium gluconate, or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg sodium fluoride/kg of body weight (i.e. more than 6.9 mg sodium fluoride/lb of body weight), induce vomiting and seek emergency medical help."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL KIRKMAN LABORATORIES, INC. SODIUM FLUORIDE TABLETS Dye-free! Cherry Flavored Chewable Sodium Fluoride Tablets USP CAUTION: Federal law prohibits dispensing without prescription A product of KIRKMAN LABORATORIES, INC. Lake Oswego, OR 97035 2.21 mg NaF = 1 mg Fluoride Ion 100 Tablets NDC 58223-679-01 Each tablet contains 2.21 mg of Sodium Fluoride equivalent to 1 mg of the fluoride ion. INGREDIENTS: Sodium Fluoride USP, Lactose, Cherry Flavor, Saccharin Sodium, Magnesium Stearate. Dispense in light resistant, tight container as defined in the USP. Keep bottle tightly closed. Keep Out of the Reach of Children. Manufactured for: Kirkman Laboratories, Inc., Lake Oswego, OR 97035 FL035 BERMUDA GOVERNMENT PREVENTIVE DENTAL PROGRAM For School Use Only Sodium Fluoride 2.21 MG (1.0 mg Fluoride) 1000 TABLETS FOR CLASS DISTRIBUTION ONLY DAILY DOSE: One tablet per child per day for children ages 6-13. *KEEP THIS BOTTLE OUT OF REACH OF CHILDREN* • It is important to keep to the correct dosage. • Do not give these tablets along with any other tablets that contain fluoride (such as vitamin-fluoride combinations) • Keep this bottle in a safe, cool place. • For further information, Tel. (441) 278-6440. Senior Dental Office, Dept. of Health Victoria Street, Hamilton Bermuda Each tablet contains 2.21 mg of Sodium Fluoride USP, equivalent to 1.0 mg of the fluoride ion. INGREDIENTS: Sodium Fluoride USP, Lactose, Cherry Flavor, Saccharin Sodium, Magnesium Stearate. DYE FREE! KIRKMAN LABORATORIES INC. LAKE OSWEGO, OR 97035 LABEL P/N #: FL045 Bulk #: 679-04 Lot #: 00000000 Pkg. Date: 00/00 Exp. Date: 00/00 BERMUDA GOVERNMENT PREVENTIVE DENTAL PROGRAM For Individual Use Only Sodium Fluoride 2.21 MG (1.0 mg Fluoride) For Home Treatment (70 Tablets) Name: ____________________________________ School:________________________ Grade:_____ DAILY DOSE: One tablet per child per day for children ages 6 to 13. • KEEP OUT OF THE REACH OF CHILDREN. • It is important to keep to the correct dosage. • Do not give these tablets along with any other tablets that contain fluoride (such as vitamin-fluoride combinations) • Keep this bottle in a safe, cool place. • For further information, Tel. (441) 278-6440 Senior Dental Office, Dept. of Health Victoria Street, Hamilton Bermuda Each tablet contains 2.21 mg of Sodium Fluoride USP, equivalent to 1.0 mg of the fluoride ion. INGREDIENTS: Sodium Fluoride USP, Lactose, Cherry Flavor, Saccharin Sodium, Magnesium Stearate. DYE FREE! KIRKMAN LABORATORIES INC. LAKE OSWEGO, OR 97035 LABEL P/N #: FL044 Bulk #: 679-70 Lot #: 00000000 Pkg. Date: 00/00 Exp. Date: 00/00"],"pediatric_use":["Pediatric Use: The use of Kirkman's 2.21 mg Sodium Fluoride Tablets as a caries preventive in pediatric age groups 6 months to 16 years is supported by evidence from adequate and well-controlled studies on fluoride supplementation from birth through adolescence."],"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."],"set_id":"ac5896fa-0d33-7132-e63e-37786e914f12","spl_product_data_elements":["SODIUM FLUORIDE CHERRY SODIUM FLUORIDE Sodium Fluoride Fluoride Ion Lactose, Unspecified Form Saccharin Sodium Magnesium Stearate F2 2.2 mg label 2.2 mg label Sodium Fluoride Tablets Label"],"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"],"version":"4","warnings":["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."]}