Daily oral dose: (in areas where the drinking water contains less than 0.3 ppm F): 6 months to age 3: one-half dropperful (1/2 mL); age 3-6, one dropperful (1 mL); age 6-16, two dropperfuls (2 mL). When drinking water is partially fluoridated (0.3 to 0.6 ppm F inclusive) dose as follows: 6 months to age 3, fluoride supplementation not indicated; age 3-6, one-half dropperful (1/2 mL); age 6-16, one dropperful (1 mL...
www.fda.gov/med-watch
www.h2-pharma.com| Supplement Facts | ||
|---|---|---|
| Serving Size 1.0 mL | ||
| Servings Per Container 50 | ||
| Amount Per Serving | % Daily Value | |
| Fluoride | 0.5 mg | * |
* Daily Value not established
*U.S. Recommended Daily Allowance not established. Consult your physician for use by infants and children under 2 years of age.
Active Ingredient: Sodium fluoride 0.11% (w/v).
Other Ingredients: Citric acid, methyl paraben, peach flavor, purified water, red #33, sodium benzoate, sodium fluoride, sucralose, yellow #6.
These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.
| AGE | 0-0.3 PPM | 0.3-0.6 PPM | > 0.6 PPM |
|---|---|---|---|
| 6 months to 3 years | 0.25 mg F = 1/2 mL = Half dropperful | 0 | 0 |
| 3-6 years | 0.5 mg F = 1 mL = One dropperful | 0.25 mg F = 1/2 mL = Half dropperful | 0 |
| 6-16 years | 1 mg F = 2 mL = Two dropperfuls | 0.5 mg F = 1 mL = One dropperful | 0 |
* Conforms to new ADA and AAP guidelines for supplementation.
Each 1 mL contains 0.5 mg fluoride ion (F-) from 1.1 mg of sodium fluoride (NaF). For use as a dental caries preventative in pediatric patients. Sugar-free and saccharin-free. Active Ingredient: Sodium fluoride 0.11% (w/v). Other Ingredients: Citric acid, methyl paraben, peach flavor, purified water, red #33, sodium benzoate, sodium fluoride, sucralose, yellow #6.
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 demineralization and by inhibiting the cariogenic microbial process.
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. Sodium Fluoride Drops 0.5 mg were developed to provided systemic fluoride for use as a supplement for patients living in areas where the drinking water fluoride level does not exceed 0.6 ppm F. See guidelines for supplementation from ADA and AAP.
Do not use in areas where drinking water exceed 0.6 ppm F. Do not administer to patients less than 6 months old.
See "CONTRAINDICATIONS" above.
See "OVERDOSAGE" section. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed. Not for ophthalmic use.
Allergic rash or other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact H2-Pharma at 1-866-592-6438 or the FDA at 1-800-FDA-1088 or www.fda.gov/med-watch.
Prolonged daily ingestion of excessive fluoride will result in varying degrees of dental fluorosis. For safety purposes, the total amount of sodium fluoride in a 50 mL bottle of Sodium Fluoride Drops 0.5 mg (25 mg F) conforms with the recommendations of the American Dental Association for the maximum to be dispended at one time.
Daily oral dose: (in areas where the drinking water contains less than 0.3 ppm F): 6 months to age 3: one-half dropperful (1/2 mL); age 3-6, one dropperful (1 mL); age 6-16, two dropperfuls (2 mL). When drinking water is partially fluoridated (0.3 to 0.6 ppm F inclusive) dose as follows: 6 months to age 3, fluoride supplementation not indicated; age 3-6, one-half dropperful (1/2 mL); age 6-16, one dropperful (1 mL)3
3 Conforms to new ADA and AAP guidelines for supplementation.
Sodium Fluoride Drops 0.5 mg are available in 50 mL bottles with an accompanying calibrated dropper.
Do not accept if printed bottle seal around cap is broken or missing.
Accepted Dental Therapeutics, Ed. 40. American Dental Association, Chicago, 1984, p.339-402. Jakush, J, New Fluoride schedule adopted. ADA New, May 16, 1994, p. 12, 14.
Store at controlled room temperature, 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. After opening, store away from direct light. Close tightly after each use. REFRIGERATION IS NOT REQUIRED.
Distributed by: H2-Pharma, LLC
2010 Berry Chase Place, Montgomery, AL 36117www.h2-pharma.com
61269-165-50
Sodium Fluoride
Drops
Peach Flavored
Sugar-free and Saccharin-free
1⅔ fl. oz. (50 mL)
0.5 mg
H2 pharma
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61269-165-50 | Sodium Fluoride Drops | 50 mL in 1 BOTTLE | SOLUTION/ DROPS | 50 | 4 | |
| 61269-165-50 | Sodium Fluoride Drops | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 4 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61269-165-50 | ML - Milliliter | 61269-165 | 15ce4f32-e06d-46b4-aaa2-84f6d85933ad | 1 | 2017-04-05 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61269-165 | 61269-165-50 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PEACH | 3OKE88I3QG | IACT |
| WATER | 059QF0KO0R | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
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.
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