Fluoride Chewable Tablets (Sodium Fluoride) 0.25 mg
by Cypress Pharmaceutical · tablet or pill · 120 chewable tablets
- On the market (NIH)
- DSLD label 12949
- Serving 0.25 to 1 tablets; amounts per 1 tablet
Fluoride Chewable Tablets (Sodium Fluoride) 0.25 mg by Cypress Pharmaceutical lists one ingredient: sodium fluoride, without an amount per serving of 1 tablet. Its current label entered the NIH Dietary Supplement Label Database on October 25, 2012.
What is in Fluoride Chewable Tablets (Sodium Fluoride) 0.25 mg?
Each row as the label prints it, per serving of 1 tablet. The capsule beside an amount places it among every product in the NIH database that lists the same ingredient: the bar is the middle half of their amounts, the line in it the median, the whiskers the 10th and 90th percentiles; the green tick is the FDA Daily Value and the red dashed tick the adult upper limit (IOM).
| Ingredient | Amount | % DV | Among products listing it |
|---|---|---|---|
| Sodium Fluoride | no amount given |
Source: NIH ODS Dietary Supplement Label Database, label 12949 (entered October 25, 2012), version 9.4.0. See the label on DSLD. Amounts are what the maker printed; DSLD does not test products. Daily Values: the FDA's Daily Value page.
Is that a lot?
Every amount on this label with a position sits within the middle 80% of the products that list the same ingredient; 1 ingredient sits inside a blend, so their amounts cannot be compared.
The NIH database records one serving a day from the label's directions; its % Daily Values are for adults and children 4 or more years of age. The directions as printed are further down this page.
The Tolerable Upper Intake Level is the most of a nutrient per day, from food, water and supplements together, that is likely to pose no risk for almost all adults (Institute of Medicine, 2011). It does not apply under medical supervision. This page compares labels; it is not medical advice.
Sources: amounts from the DSLD label; Daily Values from 21 CFR 101.9(c)(8)(iv); adult upper limits from the Institute of Medicine's DRI summary tables (2011). How positions are computed.
Which products have the closest formulas?
6 products list the very same ingredients; the nearest amounts come first.
- D Aspartic AcidReaction Nutrition same ingredients
- Probiotic Bio-Tract TechnologyVitamin World same ingredients
- Diabetic SupportOmojo · off the market same ingredients
- Seaweed Detox FormulaOmojo · off the market same ingredients
- Slimming Seaweed FormulaOmojo · off the market same ingredients
- Ultimate MineralizeBeachbody same ingredients
Source: ingredient lists of every product's current label in DSLD (version 9.4.0); similarity weights each shared ingredient by how rare it is.
What does the label say about taking it?
Quoted from the label as DSLD transcribed it: the maker's words, including any claim about what the product does, which the FDA has not evaluated and PlainVitamins does not endorse.
- Directions
- INDICATIONS AND USAGE: For once daily self-applied systemic use as a dental caries preventative. 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.1
- DOSAGE2 AND ADMINISTRATION: Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth. See schedule below to determine dosage.
- Warnings
- CONTRAINDICATIONS: Fluoride 1 mg F- Tablets are contraindicated when the fluoride content of drinking water is 0.3 ppm F- or more and should not be administered to pediatric patients under age 6 years. Fluoride 0.5 mg F- Tablets 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 age 6 when the fluoride content of drinking water is 0.3 ppm For more or to pediatric patients under age 3 years. Fluoride 0.25 mg F- Tablets 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 age 3 years when the fluoride content of drinking water is 0.3 ppm F- or more. Do not administer Fluoride Chewable Tablets (any strength) to pediatric patients under age 3 years due to choking hazard.
- 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.
- 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 reach of infants and children. PRECAUTIONS: General: Please refer to the CONTRAINDICATIONS, WARNINGS and OVERDOSAGE sections for overdosage concerns. Use in pediatric patients below the age of 3 years not recommended by current American Dental Association and American Academy of Pediatrics guidelines.
- 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) have 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) have 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.
- 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 is excreted in human milk. However, many drugs are excreted in human milk and caution should be exercised when Fluoride Chewable Tablets are administered to a nursing woman. 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.
- Geriatric Use: Fluoride Chewable Tablets (any strength) are not indicated for use in geriatric patients.
- ADVERSE REACTIONS: Allergic rash and other idiosyncrasies have been rarely reported.
- Allergens and what it does not contain
- DESCRIPTION: Each Fluoride Chewable Tablet is sugar free, saccharin free and erythrosine (FD&C Red Dye #3) free.
- Storage
- STORAGE: Store in a cool, dry place at a controlled room temperature 20(0) - 25(0)C (68(0) - 77(0)F); excursions permitted to 15(0) - 30(0)C (59(0) - 86(0)F) and away from heat and sunlight. Store in original container. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.
Source: label statements in DSLD label 12949.
What else is on the label?
Other ingredients: Xylitol, Microcrystalline Cellulose, Malic Acid, Magnesium Stearate, Talc, Citric Acid, natural Orange flavor, Sucralose.
Seals and symbols as the label prints them (the maker's; a certifier's own list confirms a seal): SCI.
How many labels does Fluoride Chewable Tablets (Sodium Fluoride) 0.25 mg have?
One label is on file, entered on October 25, 2012.
- Label 12949 (current) Entered October 25, 2012 · on the market · 120 chewable tablets
Source: DSLD label entry and market events, version 9.4.0 (labels entered through September 25, 2025).
Who makes it?
The label names Cypress Pharmaceutical, Inc. (distributor), Madison, MS. All Cypress Pharmaceutical products.