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Name:Sodium Fluoride Drops
Manufacturer:Hi-tech Pharmacal Co., Inc.
Category:Prescription Marketed Drugs


Sodium Fluoride Drops

SODIUM FLUORIDE DROPS - sodium fluoride solution/ drops 
Hi-Tech Pharmacal Co., Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Sodium Fluoride Drops

DESCRIPTION

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.

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

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).

DOSAGE AND ADMINISTRATION

Dropper Image

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).

*
Conforms to new ADA and AAP guidelines for supplementation.*

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 SUPPLIED

50 mL bottles (NDC 50383-656-50)

TAMPER EVIDENT: Do not accept if printed bottle seal around cap is broken or missing.

*REFERENCES

  1. Accepted Dental Therapeutics, Ed. 40. American Dental Association. Chicago, 1984. p.399-402.
  2. 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

Container Label

Container Label - 50 mL

Carton

Carton - 50 mL


SODIUM FLUORIDE DROPS 
sodium fluoride drops solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50383-656(NDC:50383-656)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 33  
FD&C YELLOW NO. 6  
GLYCERIN  
METHYLPARABEN  
PEACH  
PROPYLPARABEN  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50383-656-50 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 50 mL in 1 BOTTLE This package is contained within the CARTON (50383-656-50)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved other 03/01/1996

Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)

Revised: 09/2009 Hi-Tech Pharmacal Co., Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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