Label: STROVITE FORTE CAPLET- vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, pantothenic acid, magnesium, zinc, selenium, copper, chromium, molybdenum, and iron tablet, coated

  • NDC Code(s): 0642-0204-10
  • Packager: Everett Laboratories, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 22, 2014

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  • SPL UNCLASSIFIED SECTION

    Supplemental Facts
    Serving Size: 1 Caplet

  • DESCRIPTION

    Each STROVITE® FORTE caplet contains:Amount Per Serving% Daily Value
    Vitamin A (acetate and beta carotene) 4000 IU 80%
    Vitamin C (ascorbic acid)500 mg833%
    Vitamin D3 (cholecalciferol) 400 IU100%
    Vitamin E (dl-alpha-tocopheryl acetate)60 IU200%
    Vitamin B1 (thiamine mononitrate)20 mg1333%
    Vitamin B2 (riboflavin)20 mg1176%
    Niacinamide (vitamin B3)100 mg500%
    Vitamin B6 (pyridoxine HCl)25 mg1250%
    Folic Acid1.0 mg250%
    Vitamin B12 (cyanocobalamin)50 mcg833%
    Biotin0.15 mg 50%
    Pantothenic acid (calcium pantothenate)25 mg250%
    Iron (ferrous fumarate)10 mg56%
    Magnesium (magnesium oxide)50 mg13%
    Zinc (zinc oxide)15 mg 100%
    Selenium (sodium selenate) 50 mcg71%
    Copper (cupric oxide)3 mg150%
    Chromium (chromium nitrate)50 mcg42%
    Molybdenum (sodium molybdate)20 mcg27%

    OTHER INGREDIENTS: Microcrystalline Cellulose, Starch, Maltodextrin, Stearic Acid, Dicalcium Phosphate, Hypromellose, Crospovidone, Polyvinylpyrrolidone, Croscarmellos Sodium, Sodium Lauryl Sulfate, Gelatin, Titanium Dioxide, Citric Acid, Soy Polysaccharide, Talc, Magnesium Stearate, Sucrose, Polyethylene Glycol, Mineral Oil, FD&C Yellow #5 Lake (Tartrazine as a color additive), Silica, FD&C Blue #1 Lake, Sodium Ascorbate, Tocopherols, Triglycerides, Tricalcium Phosphate, Ascorbyl Palmitat and BHT. Contains: Soy

  • INDICATION AND USAGE

    STROVITE® FORTE provides nutritional supplementation to support optimum vitamin and mineral levels.

  • CONTRAINDICATIONS

    STROVITE® FORTE is contraindicated in patients hypersensitive 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).

  • BOXED WARNING (What is this?)

    WARNING

    Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

  • WARNINGS/PRECAUTIONS

    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

    As little as 5 mg pyridoxine daily can decrease the efficacy of levodopa in the treatment of Parkinsonism. Therefore, STROVITE® FORTE is not recommended for patients undergoing such therapy.

    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 hypercalcemia such as hyperparathyroidism and those who form calciumcontaining 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® FORTE. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

  • DOSAGE AND ADMINISTRATION

    Usual adult dosage: one caplet daily.

  • HOW SUPPLIED

    Dark green, oblong, bisect caplets; embossed "EV 0204". Available in bottles of 100 caplets, 0642-0204-10. Store at controlled room temperature 15°-30°C (59°- 86°F). Avoid excessive heat. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

  • SPL UNCLASSIFIED SECTION

    Rx

    Manufactured for:
    EVERETT LABORATORIES, INC.
    Chatham, NJ 07928

    You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information contact 1-877-324-9349

    Rev. 12/13

    Strovite® is a trademark of Everett Laboratories, Inc.

  • PRINCIPAL DISPLAY PANEL - 100 Caplet Bottle Label

    0642-0204-10

    STROVITE® FORTE

    MULTIVITAMIN AND MINERAL
    SUPPLEMENT

    100 Caplets

    Rx

    PRINCIPAL DISPLAY PANEL - 100 Caplet Bottle Label
  • INGREDIENTS AND APPEARANCE
    STROVITE FORTE   CAPLET
    vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, pantothenic acid, magnesium, zinc, selenium, copper, chromium, molybdenum, and iron tablet, coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0642-0204
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A4000 [iU]
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid500 mg
    Vitamin D (UNII: 9VU1KI44GP) (Cholecalciferol - UNII:1C6V77QF41) Vitamin D400 [iU]
    .Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol60 [iU]
    Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine20 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin20 mg
    Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin100 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride25 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin50 ug
    Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin0.15 mg
    Pantothenic Acid (UNII: 19F5HK2737) (Pantothenic Acid - UNII:19F5HK2737) Pantothenic Acid25 mg
    Magnesium (UNII: I38ZP9992A) (Magnesium - UNII:I38ZP9992A) Magnesium50 mg
    Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc15 mg
    Selenium (UNII: H6241UJ22B) (Selenium - UNII:H6241UJ22B) Selenium50 ug
    Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5) Copper3 mg
    Chromium (UNII: 0R0008Q3JB) (Chromium - UNII:0R0008Q3JB) Chromium50 ug
    Molybdenum (UNII: 81AH48963U) (Molybdenum - UNII:81AH48963U) Molybdenum20 ug
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron10 mg
    Inactive Ingredients
    Ingredient NameStrength
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Crospovidone (UNII: 68401960MK)  
    Calcium Phosphate, Dibasic, Anhydrous (UNII: L11K75P92J)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Povidone K30 (UNII: U725QWY32X)  
    Polyethylene Glycols (UNII: 3WJQ0SDW1A)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Gelatin (UNII: 2G86QN327L)  
    Talc (UNII: 7SEV7J4R1U)  
    Sucrose (UNII: C151H8M554)  
    Sodium Ascorbate (UNII: S033EH8359)  
    Tocopherol (UNII: R0ZB2556P8)  
    C10-18 Triglycerides (UNII: 43AGM4PHPI)  
    Tricalcium Phosphate (UNII: K4C08XP666)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    FD&C Yellow no. 5 (UNII: I753WB2F1M)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorGREEN (Dark Green) Score2 pieces
    ShapeOVALSize19mm
    FlavorImprint Code EV0204
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0642-0204-10100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER10/01/1996
    Labeler - Everett Laboratories, Inc. (071170534)