Label: PRENATAL VITAMINS PLUS- vitamin a, vitamin c, vitamin d-3, vitamin e, vitamin b-1, vitamin b-2, niacin, vitamin b-6, calcium, iron, zinc, copper tablet

  • NDC Code(s): 63044-150-01, 63044-150-05
  • Packager: Nnodum Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 15, 2018

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  • PRENATAL VITAMINS PLUS LOW IRON

    Supplemental Facts 
    Each tablet Contains: Amount per Tablet % Daily Value
     Vitamin A (Acetate and Beta Carotene) 4000 I.U. 80%
     Vitamin C (Ascorbic acid) 120 mg       200%
     Vitamin D-3 (Cholecalciferol) 400 I.U. 100%
     Vitamin E (dl-Alpha Tocopheryl Acetate) 22 mg 73%
     Vitamin B-1 (Thiamine Mononitrate) 1.84 mg 123%
     Vitamin B-2 (Riboflavin) 3 mg 176%
     Niacin (Niacinaminde) 20 mg 100%
     Vitamin B-6 (Pyridoxine HCL) 10 mg 500%
     Folic Acid 1 mg 200%
     Vitamin B-12 (Cyanocobalamin) 12 mcg 200%
     Calcium (from Calcium Carbonate) 200 mg 20%
     Iron (Ferrous Fumarate 27 mg 150%
     Zinc (Zinc Oxide) 25 mg 167%
     Copper (Cupric Oxide) 2 mg 100%

  • Other Ingredients:

    Corn Starch, Dicalcium Phosphate, DL Alpha Tocopherol, FD&C: Blue #2 Lake, FD&C: Red #40 Lake, FD&C: Yellow #6 Lake, Gum Arabic, Hydroxypropyl Methylcellulose, Maltodextrin, Microcrystalline Cellulose, Modified food starch, Polyethylene Glycol (PEG), Polyvinyl Alcohol, Pregelatinized Starch, Silicon Dioxide, Sucrose, Talc, Titanium Dioxide.

  • Directions:

    Before, during and after pregnancy, one tablet daily or as directed by physician.

  • Caution:

    Folic Acid may partially correct the hematological damage due to Vitamin B-12 deficiency or pernicious anemia while the associated neurological damage progresses.

  • Warning:

    Accidental overdose of iron-containing products is a leading cause of fetal poisoning in children under six.

    KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

    In case of acciential overdose, call a physician or Poison Control Center immediately.

  • Indications:

    To promote 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.

  • Contraindications:

    This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

  • Storage:

    Store at room temperature, USP. Dispense in a well closed light resistant container.

  • Safety Information:

    DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

  • Prenatal Vitamins PlusLow iron tablets product label

    Rx Only NDC 63044-150-05

    Prenatal Vitamins Plus
    Low iron tablets

    Vitamins and Mineral
    Supplement for pregnant
    & lactating women

    ZIKS Nnodum Pharmaceuticals

    500 Tablets

    Manufactured for: Nnodum Pharmaceuticals
    Cincinnati, OH 45240 (513) 861-2329
    MADE IN THE USA

    Nnodum PreNatalVit

  • INGREDIENTS AND APPEARANCE
    PRENATAL VITAMINS PLUS 
    vitamin a, vitamin c, vitamin d-3, vitamin e, vitamin b-1, vitamin b-2, niacin, vitamin b-6, calcium, iron, zinc, copper tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63044-150
    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 (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE22 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE ION1.84 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 CARBONATE200 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 mg
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER2 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ACACIA (UNII: 5C5403N26O)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (peach) Scoreno score
    ShapeOVALSize7mm
    FlavorImprint Code N150
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63044-150-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/25/2016
    2NDC:63044-150-05500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/25/2016
    Labeler - Nnodum Pharmaceuticals (960457273)
    Registrant - Nnodum Pharmaceuticals (960457273)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nnodum Pharmaceuticals960457273manufacture(63044-150)
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