Label: PRENATAL PLUS- vitamin a acetate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide tablet, film coated

  • NDC Code(s): 65162-668-10, 65162-668-50
  • Packager: Amneal Pharmaceuticals, LLC
  • 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 2, 2013

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  • DESCRIPTION

    Each Tablet Contains:

    VITAMINS:                                                                        Amount per Tablet

    Vitamin A (from Acetate and Beta Carotene) ............................. 4000 IU

    Vitamin C (Ascorbic Acid) ........................................................... 120 mg

    Vitamin D-3 (Cholecalciferol) ....................................................... 400 IU

    Vitamin E (dl- Alpha Tocopheryl Acetate) ...................................... 22 IU

    Thiamine (Vitamin B-1) (from Thiamine Mononitrate) ................. 1.84 mg

    Riboflavin (Vitamin B-2) .................................................................. 3 mg

    Niacin (as Niacinamide) ................................................................ 20 mg

    Vitamin B-6 (Pyridoxine HCl) ......................................................... 10 mg

    Folic Acid ......................................................................................... 1 mg

    Vitamin B-12 (Cyanocobalamin) ................................................... 12 mcg

    MINERALS:                                                                         Amount per Tablet

    Calcium (as Calcium Carbonate) ................................................. 200 mg

    Iron (from Ferrous Fumarate) ........................................................ 27 mg

    Zinc (from Zinc Oxide) ................................................................... 25 mg

    Copper (from Cupric Oxide) ........................................................... 2 mg

    Other ingredients: croscarmellose sodium, FD&C Blue #2, FD&C Red #40, FD&C Yellow # 5, FD&C Yellow # 6, macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, silicon, starch, stearic acid, talc, titanium dioxide

  • INDICATIONS AND USAGE

    To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception.

  • WARNINGS

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

    Folic acid may partially correct the hematological damage due to Vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progesses.

  • DOSAGE AND ADMINISTRATION

     As a dietary adjunct before, during and after pregnancy, take one tablet daily with a meal, or as directed by a physician.

  • HOW SUPPLIED

    Bottles of 100:        NDC 65162-668-10

    Bottles of 500:         NDC 65162-668-50

    Storage

    STORE AT CONTROLLED ROOM TEMPERATURE 15º to 30ºC (59º to 86ºF), AVOID EXCESS HEAT.

    Dispense in a well closed light-resistant container, with a child resistant cap.
    KEEP THIS AND ALL MEDICATION OUR OF THE REACH OF CHILDREN.
    DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.

    Manufactured by:
    Nexgen Pharma
    Colorado Springs, CO  80905

    Distributed by:
    Amneal Pharmaceuticals
    Glasgow, KY  42141

    Rev. 09-2012

  • PRINCIPAL DISPLAY PANEL

     Prenatal Plus Label

  • INGREDIENTS AND APPEARANCE
    PRENATAL PLUS 
    vitamin a acetate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65162-668
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A3080 [iU]
    .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE920 [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 mg
    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 CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 mg
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBIC ACID (UNII: X045WJ989B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code G12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65162-668-10100 in 1 BOTTLE, PLASTIC
    2NDC:65162-668-50500 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER12/02/2009
    Labeler - Amneal Pharmaceuticals, LLC (123797875)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nexgen Pharma, Inc.806784679ANALYSIS(65162-668) , MANUFACTURE(65162-668)