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| Product NDC Code | 59088-105 | ||||
|---|---|---|---|---|---|
| Drug Name | Fluoride |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 313036 | ||||
| Labeler Name | PureTek Corporation | ||||
| Packages |
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Overdosage of Fluoride
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSAGE Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e. less than 2.3 mg fluoride/lb body weight) has been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e. more than 2.3 mg fluoride/lb body weight) has been ingested, induce vomiting, give orally soluble calcium (e.g. milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e. more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.
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 rarely been reported. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Fluoride Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.Drug Interactions Do not eat or drink dairy products within one hour of fluoride administration. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride, which is poorly absorbed.
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 Fluoride Chewable Tablets 0.5 mg are contraindicated when the fluoride content of drinking water is more than 0.6 ppm F* and should not be administered to pediatric patients under 6 years of age when the fluoride content of drinking water is 0.3 ppm F* or to pediatric patients under age 3 years. Do not administer Fluoride Chewable Tablets (any strength) to pediatric patients under age 6 months.
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 Fluoride Chewable Tablet 0.5 mg is erythrosine (FD&C Red Dye No. 3) free. Each tablet contains 0.5 mg F* from 1.1 mg sodium fluoride (NaF). Each tablet for oral administration contains sodium fluoride equivalent to fluoride 0.5 mg and the following inactive ingredients: croscarmellose sodium, D&C Red No. 27 aluminum lake, FD&C Blue No. 1 aluminum lake, grape flavor, magnesium stearate, mannitol, microcrystalline cellulose, sucrose.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients croscarmellose sodium, D&C Red No. 27 aluminum lake, FD&C Blue No. 1 aluminum lake, grape flavor, magnesium stearate, mannitol, microcrystalline cellulose, sucrose.
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 For once daily self-applied systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water (1 ppm F*) during the period of tooth development results in a significant decrease in the incidence of dental caries. Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to 3 years of age and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm F*.
Spl product data elements
Usually a list of ingredients in a drug product.Fluoride Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION CROSCARMELLOSE SODIUM D&C RED NO. 27 FD&C BLUE NO. 1 MAGNESIUM STEARATE MANNITOL MICROCRYSTALLINE CELLULOSE SUCROSE Grape flavor 105 Light purple
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.Carcinogenesis, Mutagenesis, Impairment of Fertility In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported for male rats treated with 2.5 mg and 4.1 mg of body weight. In a second study, no carcinogenesis was observed in rats, males or females treated with fluoride up to 11.3 mg/kg of body weight. This dose is at least 400 times greater than the recommended daily dose of Fluoride Chewable Tablets. Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those in which humans are exposed. In vivo data is conflicting. Some studies report chromosome damage in rodents while other studies using similar protocols report negative results. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower doses of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. This dose is approximately 200 times greater than the recommended daily dose of Fluoride Chewable Tablets.
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.image description
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.Geriatric Use Fluoride Chewable Tablets 0.5 mg are not indicated for use in geriatric patients.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers It is not known if fluoride ion is excreted in human milk. However, many drugs are excreted in human milk and caution should be exercised when Fluoride Chewable Tablets 0.5 mg are administered to nursing women. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. This dose is at least 200 times greater than the recommended daily dose of Fluoride Chewable Tablets.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use The use of Fluoride Chewable Tablets 0.5 mg as a caries preventive in pediatric age groups 6 months to 16 years is supported by evidence from adequate and well-controlled studies on fluoride supplementation from birth through adolescence.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. Epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.
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 Chewable tablets containing 0.5 mg fluoride are purple-colored, grape flavor, un-scored, round, debossed “105”. Available in bottles of 120’s and 1000’s. NDC:59088-105-73
Storage and handling
Information about safe storage and handling of the drug product.STORAGE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. *F from sodium fluoride.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS General: Please refer to CONTRAINDICATIONS, WARNINGS, OVERDOSAGE sections for overdosage concerns. Use in pediatric patients below the age of 6 months is not recommended by current American Dental Association and American Academy of Pediatrics guidelines. Drug Interactions Do not eat or drink dairy products within one hour of fluoride administration. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride, which is poorly absorbed. Carcinogenesis, Mutagenesis, Impairment of Fertility In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported for male rats treated with 2.5 mg and 4.1 mg of body weight. In a second study, no carcinogenesis was observed in rats, males or females treated with fluoride up to 11.3 mg/kg of body weight. This dose is at least 400 times greater than the recommended daily dose of Fluoride Chewable Tablets. Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those in which humans are exposed. In vivo data is conflicting. Some studies report chromosome damage in rodents while other studies using similar protocols report negative results. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower doses of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. This dose is approximately 200 times greater than the recommended daily dose of Fluoride Chewable Tablets. Pregnancy Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. Epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood. Nursing Mothers It is not known if fluoride ion is excreted in human milk. However, many drugs are excreted in human milk and caution should be exercised when Fluoride Chewable Tablets 0.5 mg are administered to nursing women. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. This dose is at least 200 times greater than the recommended daily dose of Fluoride Chewable Tablets. Pediatric Use The use of Fluoride Chewable Tablets 0.5 mg as a caries preventive in pediatric age groups 6 months to 16 years is supported by evidence from adequate and well-controlled studies on fluoride supplementation from birth through adolescence. Geriatric Use Fluoride Chewable Tablets 0.5 mg are not indicated for use in geriatric patients.
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 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