{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-01", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "spl_product_data_elements": [ "Flotrex Multivitamins, Sodium Fluoride 0.5 mg SUCROSE CROSCARMELLOSE SODIUM D&C RED NO. 27 FD&C BLUE NO. 1 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE STEARIC ACID ASPARTAME SODIUM FLUORIDE FLUORIDE ION VITAMIN A VITAMIN A ASCORBIC ACID ASCORBIC ACID SODIUM ASCORBATE ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- THIAMINE MONONITRATE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN Grape flavor Dark purple" ], "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) ..................................................................... 0.5 mg Flotrex™ Multivitamin Chewable plus 0.5 mg Fluoride Tablets Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex™ Multivitamin Chewable plus 0.5 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid (Vegetable), Sucrose, CI 42090 (FD&C Blue No. 1 Aluminum Lake), CI 45410 (Red 27 Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet." ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries. Flotrex™ Multivitamin Chewable plus 0.5 mg Fluoride Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride. Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation: Ca 10 (PO 4 ) 6 (OH) 2 + 2F - ------- Ca 10 (PO 4 ) 6 F 2 + 2OH - (Hydroxyapatite) (Fluorapatite) Three stages of fluoride deposition in tooth enamel can be distinguished: 1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed. 2. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted. 3. After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva." ], "indications_and_usage": [ "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." ], "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 0.5 mg Fluoride Tablets provide 0.50 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 0.5 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 0.5 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 0.5 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." ], "warnings": [ "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." ], "precautions": [ "PRECAUTION The suggested dose of Flotrex™ Multivitamin Chewable plus 0.5 mg Fluoride Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride. Before prescribing Flotrex™ Multivitamin Chewable plus 0.5 mg Fluoride Tablets: 1. Determine the fluoride content of the drinking water from all major sources. 2. Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste. 3. Periodically check to make sure that the child does not develop significant dental fluorosis. Folate in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.There is a potential danger in administering folate to patients with undiagnosed anemia, since folate may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia. The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered." ], "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." ], "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." ], "how_supplied": [ "HOW SUPPLIED Flotrex™ Multivitamin Chewable plus 0.5 mg Fluoride Tablets are purple-colored, grape-flavored, unscored tablets available by prescription only in bottles of 30 tablets. (NDC: 59088-015-54). 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." ], "storage_and_handling": [ "STORAGE Do not use if bottle seal is broken. Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]." ], "package_label_principal_display_panel": [ "Flotrex™ Multivitamin Chewable plus 0.5 mg Fluoride Tablets Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 Questions? Call toll-free: 1-877-921-7873 Label" ], "set_id": "2e0e51f3-ee2c-540d-e063-6294a90a9275", "id": "39ed08e8-1c02-d4d1-e063-6394a90af98f", "effective_time": "20250714", "version": "4", "openfda": { "brand_name": [ "Flotrex" ], "generic_name": [ "MULTIVITAMINS, SODIUM FLUORIDE 0.5 MG" ], "manufacturer_name": [ "PureTek Corporation" ], "product_ndc": [ "59088-015" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ ".ALPHA.-TOCOPHEROL ACETATE, DL-", "ASCORBIC ACID", "CHOLECALCIFEROL", "CYANOCOBALAMIN", "FOLIC ACID", "NIACINAMIDE", "PYRIDOXINE HYDROCHLORIDE", "RIBOFLAVIN", "SODIUM ASCORBATE", "SODIUM FLUORIDE", "THIAMINE MONONITRATE", "VITAMIN A" ], "spl_id": [ "39ed08e8-1c02-d4d1-e063-6394a90af98f" ], "spl_set_id": [ "2e0e51f3-ee2c-540d-e063-6294a90a9275" ], "package_ndc": [ "59088-015-54" ], "is_original_packager": [ true ], "nui": [ "N0000193618", "M0001797", "M0022797", "N0000175952", "M0022794", "N0000175951", "M0022788", "N0000175950" ], "pharm_class_epc": [ "Vitamin C [EPC]", "Vitamin D [EPC]", "Vitamin B12 [EPC]", "Vitamin A [EPC]" ], "pharm_class_cs": [ "Ascorbic Acid [CS]", "Vitamin D [CS]", "Vitamin B 12 [CS]", "Vitamin A [CS]" ], "unii": [ "WR1WPI7EW8", "PQ6CK8PD0R", "1C6V77QF41", "P6YC3EG204", "935E97BOY8", "25X51I8RD4", "68Y4CF58BV", "TLM2976OFR", "S033EH8359", "8ZYQ1474W7", "8K0I04919X", "81G40H8B0T" ] } } ] }