Label: PREPLUS- vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, ferrous fumarate, zinc oxide, and cupric oxide tablet

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated March 1, 2021

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

  • HEALTH CLAIM

    Supplement Facts
    Serving Size: 1 Tablet
    Amount Per Serving%Daily Value
    for Pregnant
    and Lactating
    Women
    Vitamin A (as Acetate and Beta Carotene)4000 IU50%
    Vitamin C (Ascorbic Acid)120 mg200%
    Vitamin D (Vitamin D3 as cholecalciferol)400 IU100%
    Vitamin E (dl-Alpha Tocopheryl Acetate)22 IU73%
    Thiamine (Vitamin B1 from Thiamine Mononitrate)1.84 mg108%
    Riboflavin (Vitamin B2)3 mg150%
    Niacin (Niacinamide)20 mg100%
    Vitamin B6 (as Pyridoxine HCl)10 mg400%
    Folic Acid1 mg125%
    Vitamin B12 (Cyanocobalamin)12 mcg150%
    Calcium200 mg15%
    Iron (Ferrous Fumarate)27 mg150%
    Zinc (Zinc Oxide)25 mg167%
    Copper (Cupric Oxide)2 mg100%

    Other Ingredients: Microcrystalline Cellulose Kosher, Stearic Acid Kosher, Croscarmellose Sodium Kosher, Magnesium Stearate Kosher, Silicon Dioxide Kosher, FD&C Red #40 (Lakes), FD&C Blue #2 Aluminum Lake, and FD&C Yellow Lake #5.

    Contains FD&C Red #40 (Lakes), FD&C Blue #2 Aluminum Lake, and FD&C Yellow Lake #5.

  • DESCRIPTION

    PrePLUS (PNV-Ca with 27 mg Fe; 1 mg FA) Tablet is an orally administered prenatal/postnatal prescription folic acid-containing dietary supplement and should be administered under the supervision of a licensed medical practitioner.

  • DOSAGE AND ADMINISTRATION

    Before, during and/or after pregnancy, one tablet daily, with a meal, or as directed by a licensed healthcare practitioner regardless of lactation status.

  • WARNINGS

    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.
  • CAUTION

    High levels of folic acid may, especially in older adults, hide signs of Vitamin B-12 deficiency (such as pernicious anemia), a condition that can cause nerve damage.

  • SAFE HANDLING WARNING

    Store at 15° – 30°C (59° – 86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container. Notice: Contact with moisture may produce surface discoloration or erosion.

  • HEALTH CLAIM

    Call your licensed medical practitioner about side effects. You may report side effects by calling Virtus at 1-888-848-3593 or 1-800-FDA-1088.

  • HOW SUPPLIED

    Supplied as beige tablet, imprinted "V258" dispensed in bottles of 500 tablets.

  • HEALTH CLAIM

    Manufactured for:
    Virtus Pharmaceuticals, LLC
    Tampa, Florida 33619
    1-888-848-3593

    Rev. 03/15

  • PREPLUS (VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, ZINC OXIDE, AND CUPRIC OXIDE) TABLET

    Label Image
  • INGREDIENTS AND APPEARANCE
    PREPLUS 
    vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, ferrous fumarate, zinc oxide, and cupric oxide tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:50090-3544(NDC:69543-258)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A4000 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-22 [iU]
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.84 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE10 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP) CALCIUM200 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:50090-3544-130 in 1 BOTTLE, PLASTIC
    2NHRIC:50090-3544-0100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT07/17/2015
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)19 mm
    imprint
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-3544) , REPACK(50090-3544)