Sodium Fluoride
RxNorm 315102· SODIUM FLUORIDE· ORAL
Method Pharmaceuticals, LLC
Indications and usage
Indications and Usage As a supplemental source of Fluoride. 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.
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. Keep out of the reach of infants and children.
Contraindications
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.
Adverse events
Most frequently reported events (FDA FAERS). Report frequency does not imply causation.
- drug ineffective384
- fatigue366
- nausea339
- pain299
- diarrhoea294
- vomiting261
- pneumonia242
- dizziness241
- headache239
- pyrexia236
- dyspnoea235
- weight decreased232
- condition aggravated228
- rash226
- arthralgia214
- nasopharyngitis207
Adverse reactions (label)
Adverse Reactions Allergic rash and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or Method Pharmaceuticals, LLC at 877-250-3427. Store at controlled room temperature 15° to 30°C (59° to 86°F).
View more: Full FDA label on DailyMed →Label effective 20251021