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| Product NDC Code | 58657-322 | ||||
|---|---|---|---|---|---|
| Drug Name | Sodium fluoride |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SOLUTION/ DROPS | ||||
| RxCUI drug identifier | 315102 | ||||
| Labeler Name | Method Pharmaceuticals, LLC | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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).
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.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.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.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.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.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, Alcohol Free, Dye Free and Gluten Free. Supplement Facts Serving Size: 1 mL Servings Per Container: 50 Amount per serving % Daily Value Fluoride (as Sodium Fluoride) 0.5 mg ** ** Daily Value not established. Active Ingredients: Sodium Fluoride (0.11% w/v). Other Ingredients: Glycerin, methylparaben, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose. FLUORIDE SUPPLEMENT DOSAGE SCHEDULES AGE Fluoride Ion Level in Drinking Water (ppm)* < 0.3 ppm 0.3 - 0.6 ppm > 0.6 ppm Birth to 6 months None None None 6 months to 3 years Half dropperful 0.25 mg F (1/2 mL) None None 3 to 6 years One dropperful 0.5 mg F (1 mL)† Half dropperful 0.25 mg F (1/2 mL) None 6 to 16 years Two dropperfuls 1 mg F (2 mL) One dropperful 0.5 mg F (1 mL) None * 1.0 ppm = 1 mg/Liter † 1.1 mg Sodium Fluoride contains 0.5 mg Fluoride ion Fluoride Supplement Dose Schedule approved by the American Dental Association, American Academy of Pediatrics and American Academy of Pediatric Dentistry. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
| Birth to 6 months | None | None | None |
| 6 months to 3 years | Half dropperful 0.25 mg F (1/2 mL) | None | None |
| 3 to 6 years | One dropperful 0.5 mg F (1 mL)† | Half dropperful 0.25 mg F (1/2 mL) | None |
| 6 to 16 years | Two dropperfuls 1 mg F (2 mL) | One dropperful 0.5 mg F (1 mL) | None |
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Spl product data elements
Usually a list of ingredients in a drug product.Sodium Fluoride Sodium Fluoride GLYCERIN METHYLPARABEN PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCRALOSE SODIUM FLUORIDE FLUORIDE ION
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL NDC 58657-322-50 Sodium Fluoride Drops Sodium Fluoride Oral Solution, USP 0.5 mg/mL GRAPE FLAVORED 1.69 FL. OZ. (50 mL) carton label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.SODIUM FLUORIDE- sodium fluoride solution/ drops S odium Fluoride Drops 0.5 mg/mL GRAPE FLAVORED
Dosages and Administration Daily oral dose: (in areas where the drinking water contains less than 0.3 ppm F) age 6 months to 3 years: one half dropperful (1/2 mL); age 3 to 6 years, one dropperful (1 mL); age 6 to 16 years, two dropperfuls (2 mL). When drinking water is partially fluoridated (0.3 to 0.6 ppm F inclusive) dose as follows: age 6 months to 3 years, Fluoride supplementation not indicated; age 3 to 6 years, one half dropperful (1/2 mL); age 6 to 16 years, one dropperful (1 mL).
References
This field may contain references when prescription drug labeling must summarize or otherwise relay on a recommendation by an authoritative scientific body, or on a standardized methodology, scale, or technique, because the information is important to prescribing decisions.References 1. Accepted Dental Therapeutics, Ed. 40. American Dental Association, Chicago, 1984:399-402. 2. Jakush, J, New Fluoride Schedule Adopted. ADA News. May 16, 1994:12-14. Manufactured by: Method Pharmaceuticals, LLC Fort Worth, TX 76118 Rev. 07/2018 dropper
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.How Supplied 50 mL bottles (58657-322-50)
Safe handling warning
Safe Handling WarningOverdosage Prolonged daily ingestion of excessive Fluoride may result in varying degrees of dental fluorosis. The total amount of Sodium Fluoride in a bottle of 50 mL (0.5 mg/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. If overdose is suspected, call 1-800-222-1222 (American Association of Poison Control Centers), your local poison control center (www.aapcc.org), or emergency room immediately for treatment recommendations.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.Precautions See " Overdosage " section. Incompatibility of Fluoride with dairy foods has been reported due to formation of Calcium Fluoride which is poorly absorbed. Not for use in the eyes.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API