Label: VITAFOL CAPLET- vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, and iron capsule

  • 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 September 22, 2014

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

  • SPL UNCLASSIFIED SECTION

    Rx

  • COMPOSITION

    Each caplet contains:
    Vitamin A (as acetate)6000 IU
    Vitamin C (as ascorbic acid)60 mg
    Vitamin D-3 (as cholecalciferol)400 IU
    Vitamin E (as d-alpha tocopheryl acetate)30 IU
    Thiamine Mononitrate1.1 mg
    Vitamin B-2 (as riboflavin)1.8 mg
    Niacinamide (Vitamin B-3)15 mg
    Pyridoxine HCl2.5 mg
    Folic Acid1 .0 mg
    Vitamin B-12 (as cyanocobalamin)5 mcg
    Calcium (as calcium carbonate)125 mg
    Iron (as ferrous fumarate)65 mg

    Other Ingredients: Microcrystalline Cellulose, Stearic Acid, Croscarmellose Sodium, Crospovidone, Dicalcium Phosphate, Silica, Acacia, Maltodextrin, Hypromellose, Citric Acid, Soy Polysaccharide, Sodium Lauryl Sulfate, Magnesium Stearate, Titanium Dioxide, Magnesium Silicate, Gum Arabic, Polyethylene Glycol, Mineral Oil, Polyvinylpyrrolidone, FD&C Red #40 Lake, D&C Red #27 Lake and FD&C Blue #1 Lake. Contains Soy.

  • INDICATIONS AND USAGE

    Vitafol® is indicated to provide vitamin, mineral supplementation to support optimum vitamin levels.

  • CONTRAINDICATIONS

    Vitafol® is contraindicated in patients with hypersensitivity to any of its components or color additives. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.); pyridoxine responsive anemia, or cirrhosis of the liver. Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (Vitamin B-12).

  • WARNINGS/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. Prolonged therapeutic use of iron salts may produce iron storage disease.

    WARNING

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

    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.

    Drug Interactions

    High doses of folic acid may result in decreased serum levels of the 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 calcium-containing kidney stones.

    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 breast-feeding.

    Pediatric Use

    Not for pediatric use.

  • ADVERSE REACTIONS

    Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol®.

  • DOSAGE AND ADMINISTRATION

    One caplet daily, preferably after a meal or as prescribed by a physician.

  • HOW SUPPLIED

    Vitafol® is available as a pink, capsule shaped caplet, debossed EV0072. Available in box of unit dose pack of 100 (0642-0072-12).

    Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat, moisture and protect from light.

  • SPL UNCLASSIFIED SECTION

    Rx only

    Manufactured for
    EVERETT LABORATORIES, INC.
    Chatham, NJ 07928
    1-877-324-9349

    Vitafol® is a trademark of Everett Laboratories, Inc.
    (Rev. 12/13)

  • PRINCIPAL DISPLAY PANEL - 100 Caplet Carton

    0642-0072-12

    VITAFOL®

    Multivitamin Supplement

    10 X 10 UNIT DOSE PACK

    100 CAPLETS

    Rx

    PRINCIPAL DISPLAY PANEL - 100 Caplet Carton
  • INGREDIENTS AND APPEARANCE
    VITAFOL   CAPLET
    vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, and iron capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0642-0072
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A6000 [iU]
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 mg
    Vitamin D (UNII: 9VU1KI44GP) (Cholecalciferol - UNII:1C6V77QF41) Vitamin D400 [iU]
    .Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol10 [iU]
    Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine1.1 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.8 mg
    Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin15 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride15 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin5 ug
    Calcium (UNII: SY7Q814VUP) (Calcium - UNII:SY7Q814VUP) Calcium125 mg
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron27 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)  
    Acacia (UNII: 5C5403N26O)  
    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)  
    Polyethylene Glycols (UNII: 3WJQ0SDW1A)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Povidone K30 (UNII: U725QWY32X)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    D&C Red No. 27 (UNII: 2LRS185U6K)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code EV0072
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0642-0072-12100 in 1 BOX; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER05/01/1985
    Labeler - Everett Laboratories, Inc. (071170534)