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

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

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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

    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 Other ingredients:

  • 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.

  • 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

    Label Image
  • 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:17856-0668(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) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE200 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:17856-0668-11 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER12/02/2009
    Labeler - Atlantic Biologicals Corps (047437707)
    Registrant - Atlantic Biologicals Corps (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    Atlantic Biologicals Corps047437707RELABEL(17856-0668) , REPACK(17856-0668)