Label: PRENATAL PLUS IRON- multivitamin/multimineral supplement tablet, film coated

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

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Drug Label Information

Updated January 12, 2016

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  • DESCRIPTION

    Prenatal Plus Iron Tablet is caplet shaped, film coated tablet debossed CIS 28, 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 I.U.

    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 (Carbonyl Iron)..............................................................................29 mg

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

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

    Other ingredients: Ascorbyl Palmitate, Citric Acid anhydrous, DL-alpha Tocopherol, Ethylcellulose, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow # 5 lake, FD&C Yello # 6 lake, Glucose, Gum Acacia, Hypromellose, Magnesium Stearate, Maize Starch, Maltodextrin, Methylcellulose, Microcrystalline Cellulose, Mineral Oil, Mono-and di-glycerides, Polyethyelene Glycol, Pregelatinized Corn Starch, Silicon Dioxide, Sorbic Acid, Soy Protein, Stearic Acid, Sucrose, Titanium Dioxide, Tricalcium Phosphate

  • INDICATIONS

    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

    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.

    This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yello No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

  • STORAGE

    Store at room temperature. Dispense in a well closed light resistant container with a child resistant cap.

  • HOW SUPPLIED

    NDC 0904-5339-60 plastic bottle containing 100 Tablets.

  • Principal Display Panel

    Prenatal Plus Iron Tablets (Multivitamin/Multimineral Supplement)
    31 Tabets
    10544-609-31

    Prenatal Plus Iron Tablets

  • INGREDIENTS AND APPEARANCE
    PRENATAL PLUS IRON 
    multivitamin/multimineral supplement tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10544-609(NDC:0904-5339)
    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 [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) 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
    IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION29 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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ETHYLCELLULOSE (100 MPA.S) (UNII: 47MLB0F1MV)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    ACACIA (UNII: 5C5403N26O)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLCELLULOSE (1500 MPA.S) (UNII: P0NTE48364)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    METHYL SORBATE (UNII: J3048615R1)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    Product Characteristics
    ColorYELLOW (TAN) Scoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code CIS28
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10544-609-3131 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/17/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER05/17/2010
    Labeler - Blenheim Pharmacal, Inc. (171434587)
    Registrant - Blenheim Pharmacal, Inc. (171434587)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blenheim Pharmacal, Inc.171434587repack(10544-609)