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 September 8, 2010

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  • DESCRIPTION

    Prenatal Plus Vitamin and Mineral Tablet is an Tan-Yellow colored, modified oval biconvex film coated tablet debossed G12 on one side, and provides 10 vitamins and 4 minerals to supplement the diet before, during and after pregnancy.

    Each Prenatal Plus tablet Contains:

    Vitamin A (Acetate and Beta Carotene) .......................................4000 I.U.

    Vitamin C (Ascorbic acid)……………………………………...........….120 mg

    Vitamin D-3 (Cholecalciferol)……………….....................................400 I.U.

    Vitamin E (dl- Alpha Tocopheryl Acetate)……………………...............22 mg

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

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

    Niacin(Niacinamide)……………………………………………………....  20 mg

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

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

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

    Calcium (Calcium Carbonate)……………………………….........…....200 mg

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

    Zinc (Zinc Oxide)………………………………………………...........…..25 mg

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

    Other ingredients: Ascorbyl Palmitate, Butylated Hydroxytoluene, Croscarmellose sodium, Dicalcium phosphate Dihydrate, DL-alpha-tocopherol, FD&C Blue # 2 lake, FD&C Red # 40, FD&C Red # 40 lake, FD&C yellow # 5, FD&C yellow # 6, FD&C yellow # 6 lake, Gelatin, Hypromellose, Magnesium stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized corn starch, Propylene Glycol, Silica, Sodium Ascorbate, Sodium Benzoate, Sorbic Acid, Starch, Stearic Acid, Sucrose, SUnflower Oil, Titanium dioxide, Triacetin, Triglycerides.

  • Indication

    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

  • Dosage

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

  • BOXED WARNING (What is this?)

    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 progresses.

  • STORAGE AND HANDLING

    STORE AT CONTROLLED ROOM TEMPERATURE 150 - 300C (590 - 860F). AVOID EXCESS HEAT.

  • HOW SUPPLIED

    Prenatal Plus Vitamin and Mineral Tablet

    NDC 65162-668-10: Plastic bottle containing 100 Tablets

    NDC 65162-668-50: Plastic bottle containing 500 Tablets

    Dispense in a well closed light-resistant container, with a child resistant container.
  • PRINCIPAL DISPLAY PANEL

    10544-549-31 - Bottle LabelBottle 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:10544-549(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) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A920 [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 - UNII:X66NSO3N35) THIAMINE1.84 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACIN - UNII:2679MF687A) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE10 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) (IRON - UNII:E1UOL152H7) IRON27 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg
    CUPRIC OXIDE (UNII: V1XJQ704R4) (COPPER - UNII:789U1901C5) COPPER2 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE 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)  
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Coloryellow (Tan-Yellow) Scoreno score
    ShapeOVAL (Modified Oval Biconvex) Size19mm
    FlavorImprint Code G12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10544-549-3131 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/09/2010
    Labeler - Blenheim Pharmacal, Inc. (171434587)
    Registrant - Blenheim Pharmacal, Inc. (171434587)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blenheim Pharmacal, Inc.171434587repack
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