Search by Drug Name or NDC
NDC 59088-0106-73 Fluoride 1 mg/1 Details
Fluoride 1 mg/1
Fluoride is a ORAL TABLET, CHEWABLE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PureTek Corporation. The primary component is SODIUM FLUORIDE.
MedlinePlus Drug Summary
Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 59088-0106-73Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluoride
Product Information
| NDC | 59088-0106 |
|---|---|
| Product ID | 59088-106_295f929c-f202-4d4a-987d-203ef5260592 |
| Associated GPIs | 79300020000515 |
| GCN Sequence Number | 002623 |
| GCN Sequence Number Description | fluoride (sodium) TAB CHEW 1MG(2.2MG) ORAL |
| HIC3 | D2A |
| HIC3 Description | FLUORIDE PREPARATIONS |
| GCN | 07512 |
| HICL Sequence Number | 001127 |
| HICL Sequence Number Description | FLUORIDE (SODIUM) |
| Brand/Generic | Generic |
| Proprietary Name | Fluoride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Sodium Fluoride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, CHEWABLE |
| Route | ORAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/1 |
| Substance Name | SODIUM FLUORIDE |
| Labeler Name | PureTek Corporation |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 59088-0106-73 (59088010673)
| NDC Package Code | 59088-106-73 |
|---|---|
| Billing NDC | 59088010673 |
| Package | 120 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-106-73) |
| Marketing Start Date | 2011-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.06203 |
| Pricing Unit | EA |
| Effective Date | 2024-01-17 |
| NDC Description | FLUORIDE 1 MG TABLET CHEWABLE |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 58b3e7ff-c032-4e42-823a-8ed7b93d606f Details
DESCRIPTION
Each Fluoride Chewable Tablet 1.0 mg is erythrosine (FD&C Red Dye No. 3) free. Each tablet contains 1.0 mg F* from 2.2 mg sodium fluoride (NaF). Each tablet for oral administration contains sodium fluoride equivalent to fluoride 1.0 mg and the following inactive ingredients: croscarmellose sodium, FD&C Yellow No. 6 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, orange flavor, sucrose.
CLINICAL PHARMACOLOGY
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*.
CONTRAINDICATIONS
WARNINGS
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 1.0 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.
ADVERSE REACTIONS
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.
DOSAGE AND ADMINISTRATION
HOW SUPPLIED
STORAGE
Inactive ingredients
INGREDIENTS AND APPEARANCE
| FLUORIDE
sodium fluoride tablet, chewable |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
| Labeler - PureTek Corporation (785961046) |