Multivitamins, Sodium Fluoride 0.25 Mg
FDA Drug Information • Also known as: Flotrex
- Brand Names
- Flotrex
- Drug Class
- Vitamin C [EPC], Vitamin D [EPC], Vitamin B12 [EPC], Vitamin A [EPC]
- Route
- ORAL
- Dosage Form
- TABLET, CHEWABLE
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION: Active Ingredients: Each Chewable Tablet Contains: Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid) ...................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ................................................................... 0.25 mg Flotrex™ Multivitamin Chewable plus 0.25 mg Fluoride Tablets Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex™ Multivitamin Chewable plus 0.25 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Stearic Acid (vegetable source), Sucrose, CI 45410 (Red 27 Lake), CI 42090 (FD&C Blue No. 1 Aluminum Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet.
What Is Multivitamins, Sodium Fluoride 0.25 Mg Used For?
INDICATIONS AND USAGE This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.
Dosage and Administration
DOSAGE AND ADMINISTRATION One tablet daily, to be dissolved in the mouth or chewed before swallowing. Do not give a chewable tablet to a child younger than 4 years old.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS Folate: Allergic sensitization has been reported following both oral and parenteral administration of folate. Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels.
Warnings and Precautions
WARNING Keep out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Caution: Do not eat or drink dairy products within one hour of fluoride administration. Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.
Contraindications
Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. The American Academy of Pediatrics recommends that children up to the age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. Flotrex™ Multivitamin Chewable plus 0.25 mg Fluoride Tablets provide 0.52 mg fluoride in tablet form for children 6-16 years of age in areas where the drinking water fluoride level is less than 0.3 ppm. Flotrex™ Multivitamin Chewable plus 0.25 mg Fluoride Tablets supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride. Children using Flotrex™ Multivitamin Chewable plus 0.25 mg Fluoride Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential. Flotrex™ Multivitamin Chewable plus 0.25 mg Fluoride Tablets is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.
How Supplied
HOW SUPPLIED Flotrex™ Multivitamin Chewable plus 0.25 mg Fluoride Tablets are purple-colored, grape-flavored, unscored tablets available by prescription only in bottles of 30 tablets. (NDC: 59088-017-54). Dispense in a tight, light-resistant container with a child-resistant closure, as defined in the USP/NF. All prescription substitutions using this product shall be pursuant to applicable state statutes. This is not an Orange Book product.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.