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 Saccharin-free.
Active Ingredients: Sodium Fluoride 0.11% (w/v).
Other Ingredients: D&C red #33, FD&C yellow #6, glycerin, methylparaben, peach flavor, propylparaben, purified water.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Sodium Fluoride Drops - 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.
Indications and Usage for Sodium Fluoride Drops
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. 1 Sodium Fluoride Drops were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to age 3 and older, living in areas where the drinking water fluoride level does not exceed 0.6 ppm F.
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
See “Contraindications” above.
Precautions
See “Overdosage” section. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absored. Not for use in the eyes.
Adverse Reactions
Allergic rash and other idosyncrasies have been rarely reported.
To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010
Overdosage
Prolonged daily ingestion of excessive fluoride will result in varying degrees of dental fluorosis. (The total amount of sodium fluoride in a bottle of 50 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).
Sodium Fluoride Drops Dosage and Administration
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 (1mL).
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DOSAGE SCHEDULE** WATER F CONTENT | |||
| 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 |
How is Sodium Fluoride Drops Supplied
50 mL bottles (NDC 50383-656-50)
TAMPER EVIDENT: Do not accept if printed bottle seal around cap is broken or missing.
*REFERENCES
- Accepted Dental Therapeutics, Ed. 40. American Dental Association. Chicago, 1984. p.399-402.
- Jakush, J., New Fluoride schedule adopted. ADA News. May 16, 1994, p. 12, 14.
Manufactured by:
HI-TECH PHARMACAL CO., INC.
AMITYVILLE, N.Y. 11701
MADE IN U.S.A.
Rev. 656:03 4/09
PRINCIPAL DISPLAY PANEL
NDC 50383-542-50
Poly-Vitamin Drops
WITH FLUORIDE
0.25 MG
MULTIVITAMIN AND FLUORIDE SUPPLEMENT DROPS
Rx Only
1 2/3 FL. OZ. (50 mL)
| SODIUM FLUORIDE sodium fluoride solution/ drops | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 03/01/1996 | 04/11/2012 | |
| Labeler - Hi-Tech Pharmacal Co., Inc. (101196749) |
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