Label: 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 tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 6, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    0642-0207-90

    Iron Free Multivitamin and Mineral Supplement

    Rx

  • COMPOSITION

    Each caplet contains:
    Vitamin C (as ascorbic acid)300 mg
    Vitamin D3 (as cholecalciferol)1000 IU
    Vitamin E (as d-alpha tocopheryl succinate)100 IU
    Vitamin B1 (as thiamine HCl)20 mg
    Vitamin B2 (as riboflavin)5 mg
    Niacinamide (Vitamin B3)25 mg
    Vitamin B6 (as pyridoxine HCl)25 mg
    Folic acid1 mg
    Vitamin B12 (as cyanocobalamin)50 mcg
    Biotin100 mcg
    Pantothenic Acid (as ca 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 chromic chloride)50 mcg
    Carotenoids (alpha-carotene, beta-carotene, cryptoxanthin, lutein, zeaxanthin)3000 IU
    Alpha Lipoic Acid7.5 mg
    Lutein5 mg

    Other Ingredients: Dibasic calcium phosphate, microcrystalline cellu-lose, carbohydrate, croscarmellose sodium, stearic acid, gelatin, polyvinyl alcohol, silicon dioxide, titanium dioxide (as color), polyethylene glycol, sucrose, magnesium stearate, modified food starch, soybean oil, talc, ethylcellulose, ascorbyl palmitate, mixed tocophererols, sodium ascorbate, medium chain triglycerides, dl-alpha-tocopherol.

    Contains: Soy

  • INDICATIONS AND USAGE

    STROVITE® ONE is indicated to provide nutritional supplementation to support optimum vitamin and mineral levels.

  • 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).

  • 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 Over dosage. 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.

  • 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

    One caplet daily or as directed by a physician.

  • 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).

    Store at room temperature 15°-30°C (59°-86°F). Avoid excessive heat and moisture.

  • SPL UNCLASSIFIED SECTION

    Rx

    Distributed by:
    Exeltis USA, Inc.
    Florham Park, NJ 07932

    1-877-324-9349
    www.exeltisusa.com
    ©2018 Exeltis USA, Inc.

    US Patent No. 6,863,904
    Strovite® is a trademark of Exeltis USA, Inc.

    Rev. January 2018
    2079001-01

  • 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

    PRINCIPAL DISPLAY PANEL - 90 Caplet Bottle Label
  • INGREDIENTS AND APPEARANCE
    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 tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0642-0207
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A3000 [iU]
    Calcium Pantothenate (UNII: 568ET80C3D) (Pantothenic Acid - UNII:19F5HK2737, Calcium Cation - UNII:2M83C4R6ZB) Pantothenic Acid7.5 mg
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid300 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol1000 [iU]
    .Alpha.-Tocopherol Succinate, D- (UNII: LU4B53JYVE) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .Alpha.-Tocopherol Succinate, D-100 [iU]
    Thiamine (UNII: X66NSO3N35) (Thiamine Ion - UNII:4ABT0J945J) Thiamine20 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin5 mg
    Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide25 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride25 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
    Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin100 ug
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin50 ug
    Selenium (UNII: H6241UJ22B) (Selenium - UNII:H6241UJ22B) Selenium100 ug
    Magnesium Oxide (UNII: 3A3U0GI71G) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Cation50 mg
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide25 mg
    Cupric Sulfate (UNII: LRX7AJ16DT) (Cupric Cation - UNII:8CBV67279L) Cupric Cation1.5 mg
    Manganese (UNII: 42Z2K6ZL8P) (Manganese - UNII:42Z2K6ZL8P) Manganese1.5 mg
    Chromium (UNII: 0R0008Q3JB) (Chromium - UNII:0R0008Q3JB) Chromium50 ug
    THIOCTIC ACID (UNII: 73Y7P0K73Y) (THIOCTIC ACID - UNII:73Y7P0K73Y) THIOCTIC ACID15 mg
    Lutein (UNII: X72A60C9MT) (Lutein - UNII:X72A60C9MT) Lutein5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TALC (UNII: 7SEV7J4R1U)  
    SUCROSE (UNII: C151H8M554)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code EV0207
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0642-0207-9090 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2001
    2NDC:0642-0207-031 in 1 BOX05/04/2001
    23 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER05/04/2001
    Labeler - Exeltis USA, Inc. (071170534)