{ "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": "2026-07-18", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Strovite One Caplets Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Manganese, Chromium, .Alpha.-Lipoic Acid, and Lutein HYDROXYPROPYL METHYLCELLULOSE MALTODEXTRIN STEARIC ACID MANNITOL MANGANESE MANGANESE CROSCARMELLOSE SODIUM MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE TITANIUM DIOXIDE MAGNESIUM STEARATE POLYVINYL ALCOHOL, UNSPECIFIED STARCH, CORN TALC SUCROSE POLYETHYLENE GLYCOL, UNSPECIFIED ANHYDROUS DIBASIC CALCIUM PHOSPHATE TOCOPHEROL SODIUM ASCORBATE .ALPHA.-TOCOPHEROL, DL- VITAMIN A VITAMIN A CALCIUM PANTOTHENATE PANTOTHENIC ACID CALCIUM CATION ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL SUCCINATE, D- .ALPHA.-TOCOPHEROL, D- THIAMINE THIAMINE ION RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID BIOTIN BIOTIN CYANOCOBALAMIN CYANOCOBALAMIN SELENIUM SELENIUM MAGNESIUM OXIDE MAGNESIUM CATION ZINC OXIDE ZINC OXIDE CUPRIC SULFATE CUPRIC CATION CHROMIUM CHROMIUM ALPHA LIPOIC ACID ALPHA LIPOIC ACID LUTEIN LUTEIN MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) CORN OIL EV0207" ], "spl_unclassified_section": [ "0642-0207-90 STROVITE ® ONE IRON FREE MULTIVITAMIN AND MINERAL SUPPLEMENT Rx", "KEEP OUT OF REACH OF CHILDREN. Rx MANUFACTURED IN THE USA Distributed by: Exeltis USA, Inc. Florham Park, NJ 07932 1-877-324-9349 www.exeltisusa.com ©2022 Exeltis USA, Inc. All rights reserved. US PATENT NO. 6,863,904 STROVITE ® ONE is a trademark of Exeltis Healthcare S.L. Rev. 10/2022 2079003-04" ], "description": [ "COMPOSITION Each caplet contains: Vitamin A (as beta carotene) 900 mcg RAE Vitamin C 300 mg Vitamin D (as cholecalciferol) 25 mcg Vitamin E (as d-alpha tocopheryl succinate) 67 mg Thiamin (as thiamine hydrochloride) 20 mg Riboflavin (vitamin B2) 5 mg Niacin (as niacinamide) 25 mg NE Vitamin B6 (as pyridoxine hydrochloride) 25 mg Folate (as folic acid) 1,670 mcg DFE Vitamin B12 (as cyanocobalamin) 50 mcg Biotin 100 mcg Pantothenic Acid (as calcium-D-pantothenate) 15 mg Magnesium (as magnesium oxide) 50 mg Zinc (as zinc oxide) 25 mg Selenium (as sodium selenate) 100 mcg Copper (as cupric sulfate) 1.5 mg Manganese (as manganese sulfate) 1.5 mg Chromium (as chromium chloride) 50 mcg Alpha Lipoic Acid 7.5 mg Lutein 5 mg Other ingredients: Microcrystalline cellulose, dicalcium phosphate, hydroxypropyl methylcellulose, croscarmellose sodium, polyethylene glycol, titanium dioxide, talc, maltodextrin, modified food starch, sucrose, polyvinyl alcohol, stearic acid, silica, magnesium stearate, corn oil, starch, vitamin E alcohol, sodium ascorbate, mannitol." ], "description_table": [ "
Each caplet contains:
Vitamin A (as beta carotene)900 mcg RAE
Vitamin C 300 mg
Vitamin D (as cholecalciferol)25 mcg
Vitamin E (as d-alpha tocopheryl succinate)67 mg
Thiamin (as thiamine hydrochloride)20 mg
Riboflavin (vitamin B2)5 mg
Niacin (as niacinamide)25 mg NE
Vitamin B6 (as pyridoxine hydrochloride)25 mg
Folate (as folic acid)1,670 mcg DFE
Vitamin B12 (as cyanocobalamin)50 mcg
Biotin100 mcg
Pantothenic Acid (as calcium-D-pantothenate)15 mg
Magnesium (as magnesium oxide)50 mg
Zinc (as zinc oxide)25 mg
Selenium (as sodium selenate)100 mcg
Copper (as cupric sulfate)1.5 mg
Manganese (as manganese sulfate)1.5 mg
Chromium (as chromium chloride)50 mcg
Alpha Lipoic Acid7.5 mg
Lutein5 mg
" ], "indications_and_usage": [ "INDICATIONS AND USAGE STROVITE ® ONE is indicated to provide nutritional supplementation to support optimum vitamin and mineral levels." ], "contraindications": [ "CONTRAINDICATIONS STROVITE ® ONE is contraindicated in patients with hypersensitivity to any of its components. Folic Acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (Vitamin B12)." ], "warnings_and_cautions": [ "WARNING/PRECAUTIONS Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur. Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency. Avoid overdosage. Keep out of the reach of children." ], "precautions": [ "Drug Interactions High doses of folic acid may result in decreased serum levels of anticonvulsant drugs. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hyper-calcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions. Consult appropriate references for additional specific vitamin-drug interactions. Information for Patients Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breastfeeding. Pediatric Use Not recommended for pediatric use." ], "drug_interactions": [ "Drug Interactions High doses of folic acid may result in decreased serum levels of anticonvulsant drugs. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hyper-calcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions. Consult appropriate references for additional specific vitamin-drug interactions." ], "information_for_patients": [ "Information for Patients Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breastfeeding." ], "pediatric_use": [ "Pediatric Use Not recommended for pediatric use." ], "adverse_reactions": [ "ADVERSE REACTIONS Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in STROVITE ® ONE." ], "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION One caplet daily or as directed by a physician." ], "how_supplied": [ "HOW SUPPLIED STROVITE ® ONE is a white, oblong caplet, debossed EV0207; available in bottles of 90 caplets (0642-0207-90) and as professional samples (0642-0207-03). Storage conditions: Store at room temperature 15°-30°C (59°-86°F). Avoid excessive heat and moisture." ], "storage_and_handling": [ "Storage conditions: Store at room temperature 15°-30°C (59°-86°F). Avoid excessive heat and moisture." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 90 Caplet Bottle Label 0642-0207-90 Strovite ® ONE IRON FREE MULTIVITAMIN AND MINERAL SUPPLEMENT GLUTEN AND LACTOSE FREE 90 Caplets Rx Strovite One Bottle Label" ], "set_id": "b9b71fa4-89c7-4f5b-8174-950649434ba5", "id": "30c8e7e7-7cba-c12f-e063-6394a90a41e9", "effective_time": "20250320", "version": "5", "openfda": { "brand_name": [ "Strovite One Caplets" ], "generic_name": [ "VITAMIN A, CALCIUM PANTOTHENATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL SUCCINATE, D-, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, BIOTIN, CYANOCOBALAMIN, SELENIUM, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC SULFATE, MANGANESE, CHROMIUM, .ALPHA.-LIPOIC ACID, AND LUTEIN" ], "manufacturer_name": [ "Exeltis USA, Inc." ], "product_ndc": [ "0642-0207" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ ".ALPHA.-TOCOPHEROL SUCCINATE, D-", "ALPHA LIPOIC ACID", "ASCORBIC ACID", "BIOTIN", "CALCIUM PANTOTHENATE", "CHOLECALCIFEROL", "CHROMIUM", "CUPRIC SULFATE", "CYANOCOBALAMIN", "FOLIC ACID", "LUTEIN", "MAGNESIUM OXIDE", "MANGANESE", "NIACINAMIDE", "PYRIDOXINE HYDROCHLORIDE", "RIBOFLAVIN", "SELENIUM", "THIAMINE", "VITAMIN A", "ZINC OXIDE" ], "spl_id": [ "30c8e7e7-7cba-c12f-e063-6394a90a41e9" ], "spl_set_id": [ "b9b71fa4-89c7-4f5b-8174-950649434ba5" ], "package_ndc": [ "0642-0207-90", "0642-0207-03" ], "is_original_packager": [ true ], "upc": [ "0306420207907" ], "nui": [ "N0000193618", "M0001797", "M0022797", "N0000175952", "N0000185508", "N0000175629", "N0000184306", "M0000728", "M0022794", "N0000175951", "M0022788", "N0000175950" ], "pharm_class_epc": [ "Vitamin C [EPC]", "Vitamin D [EPC]", "Standardized Chemical Allergen [EPC]", "Vitamin B12 [EPC]", "Vitamin A [EPC]" ], "pharm_class_cs": [ "Ascorbic Acid [CS]", "Vitamin D [CS]", "Allergens [CS]", "Vitamin B 12 [CS]", "Vitamin A [CS]" ], "pharm_class_pe": [ "Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]" ], "unii": [ "LU4B53JYVE", "73Y7P0K73Y", "PQ6CK8PD0R", "6SO6U10H04", "568ET80C3D", "1C6V77QF41", "0R0008Q3JB", "LRX7AJ16DT", "P6YC3EG204", "935E97BOY8", "X72A60C9MT", "3A3U0GI71G", "42Z2K6ZL8P", "25X51I8RD4", "68Y4CF58BV", "TLM2976OFR", "H6241UJ22B", "X66NSO3N35", "81G40H8B0T", "SOI2LOH54Z" ] } } ] }