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 1.1 mg Sodium Fluoride Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patie...
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 1/2 tablet 1 tablet 2 tablets 0.3 to 0.6 ppm 0 1/4 tablet 1/2 tablet 1 tablet Greater than 0.6 ppm 0 0 0 0
Store at Controlled Room Temperature, 20-25 °C (68-77 °F). See USP "Controlled Room" for further information. NDC 58223-678-01 Manufactured for KIRKMAN Laboratories, Inc 17387 SW 63 rd Ave.Lake Oswego, OR 97035
Kirkman's 1.1 mg (0.5 mg fluoride ion) Sodium Fluoride Tablets are dye free. Each 1.1 mg (half strength) tablet contains 0.5 mg of the fluoride ion (F) from 1.1 mg sodium fluoride (NaF). Each tablet for oral administration contain sodium fluoride equivalent to 0.5 mg of the fluoride ion and the following inactive ingredients: Lactose, Cherry Flavor, Saccharin Sodium and Magnesium Stearate.
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.
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 1.1 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).
Krikman's 1.1 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.
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.
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.
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.
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 1.1 mg Sodium Tablets are administered to nursing women.
The use of Kirkman's 1.1 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.
Not indicated for use in geriatric patients.
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.
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.
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 | 1/2 tablet | 1 tablet | 2 tablets |
| 0.3 to 0.6 ppm | 0 | 1/4 tablet | 1/2 tablet | 1 tablet |
| Greater than 0.6 ppm | 0 | 0 | 0 | 0 |
Store at Controlled Room Temperature, 20-25 °C (68-77 °F). See USP "Controlled Room" for further information.
NDC 58223-678-01
Manufactured for KIRKMAN Laboratories, Inc
17387 SW 63rd Ave.Lake Oswego, OR 97035
KIRKMAN LABORATORIES, INC.
SODIUM FLUORIDE TABLETS
Dye-free!
Cherry Flavored
Chewable Sodium Fluoride Tablets USP
CAUTION: Rx only
A product of
KIRKMAN LABORATORIES, INC.
Lake Oswego, OR 97035
1.1 mg NaF = 0.5 mg Fluoride Ion
100 Tablets
NDC 58223-678-01
Each tablet contains 1.1 mg of Sodium Fluoride equivalent to 0.5 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
BERMUDA GOVERNMENT PREVENTIVE DENTAL PROGRAM
For School Use Only
Sodium Fluoride 1.1 MG
(0.5 mg Fluoride)
1000 Tablets
FOR CLASS DISTRIBUTION ONLY
DAILY DOSE: One tablet per child per day for children ages 3 to 6.
*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 1.1 mg of Sodium Fluoride USP, equivalent to 0.5 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 #: FL043
Bulk #: 678-70
Lot #: 00000000
Pkg. Date: 00/00
Exp. Date: 00/00
BERMUDA GOVERNMENT PREVENTIVE DENTAL PROGRAM
For Individual Use Only
Sodium Fluoride 1.1 MG
(0.5 mg Fluoride)
For Home Treatment (70 Tablets)
Name: ____________________________________
School:________________________ Grade:_____
DAILY DOSE: One tablet per child per day for children ages 3 to 6.
• 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 1.1 mg of Sodium Fluoride USP, equivalent to 0.5 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 #: FL043
Bulk #: 678-70
Lot #: 00000000
Pkg. Date: 00/00
Exp. Date: 00/00
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58223-678-04 | EA - Each | 58223-678 | 1ec782a6-78c7-455c-a8d9-8ad31b6699ea | 1 | 2018-03-08 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Sodium Fluoride | ACTIVE INGREDIENT | 8ZYQ1474W7 | 1 | |
| Fluoride Ion | ACTIVE MOIETY | Q80VPU408O | 1 | |
| Lactose | INACTIVE INGREDIENT | J2B2A4N98G | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| Saccharin Sodium | INACTIVE INGREDIENT | SB8ZUX40TY | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58223-678 | 58223-678-01, 58223-678-04, 58223-678-70, 58223-678-09 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Sodium Fluoride | 8ZYQ1474W7 | ACTIM |
| Lactose | J2B2A4N98G | IACT |
| Saccharin Sodium | SB8ZUX40TY | IACT |
| Magnesium Stearate | 70097M6I30 | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | LIQUID / ORAL | 3 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | FILM / BUCCAL | 3 mg | ||
| Lactose | LACTOSE | J2B2A4N98G | CAPSULE / RESPIRATORY (INHALATION) | 44.4 mg | ||
| Lactose | LACTOSE | J2B2A4N98G | TABLET / BUCCAL | 296.7 mg | ||
| Lactose | LACTOSE | J2B2A4N98G | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| Lactose | LACTOSE | J2B2A4N98G | OINTMENT / TOPICAL | NA | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| Lactose | LACTOSE | J2B2A4N98G | POWDER, FOR SOLUTION / ORAL | NA | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | WAFER / ORAL | 66 mg | ||
| Lactose | LACTOSE | J2B2A4N98G | SOLUTION / RECTAL | 8 %w/v | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | CAPSULE / ORAL | 24 mg | ||
| Lactose | LACTOSE | J2B2A4N98G | SUPPOSITORY / VAGINAL | NA | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAMUSCULAR | 22 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RESPIRATORY (INHALATION) | NA | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | POWDER, FOR SUSPENSION / ORAL | 85 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | GEL / DENTAL | 0.3 %w/w | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | CONCENTRATE / ORAL | 6 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | GRANULE, FOR SOLUTION / ORAL | 5.5 mg/120ml | ||
| Lactose | LACTOSE | J2B2A4N98G | TABLET, FILM COATED / ORAL | 590 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAVENOUS | 22 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / ORAL | 3 mg | ||
| Lactose | LACTOSE | J2B2A4N98G | GRANULE, FOR SUSPENSION / ORAL | 512.5 mg/5ml | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| Lactose | LACTOSE | J2B2A4N98G | TABLET / RECTAL | 20 mg | ||
| Lactose | LACTOSE | J2B2A4N98G | TABLET, CHEWABLE / ORAL | 1412 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | PASTE, DENTIFRICE / DENTAL | 0.2 %w/w | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING / ORAL | 187 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| Lactose | LACTOSE | J2B2A4N98G | POWDER / RESPIRATORY (INHALATION) | 90 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | POWDER, FOR SOLUTION / ORAL | 199 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 mg | ||
| Lactose | LACTOSE | J2B2A4N98G | CONCENTRATE / ORAL | NA | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| Lactose | LACTOSE | J2B2A4N98G | INJECTION / INTRAVENOUS | 203.5 mg | ||
| Lactose | LACTOSE | J2B2A4N98G | INJECTION, SOLUTION / INTRAVENOUS | 0.45 %w/v | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| Lactose | LACTOSE | J2B2A4N98G | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 133 mg | ||
| Lactose | LACTOSE | J2B2A4N98G | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 133 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / TOPICAL | NA | ||
| Lactose | LACTOSE | J2B2A4N98G | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | SYRUP / ORAL | 24 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / DENTAL | NA | ||
| Lactose | LACTOSE | J2B2A4N98G | TABLET / ORAL | 2500 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RECTAL | 665 mg |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| e37075ad-f679-4744-9c9c-2e1031cc2eb0 | e01ae0e3-d15e-99c5-3ace-035d36e0bd5f | 2020-12-07 | Warnings, Adverse reactions | e01ae0e3-d15e-99c5-3ace-035d36e0bd5f |
Adverse event summaries are temporarily unavailable. Other product information remains available.