Label: PRENATAL VITAMINS PLUS LOW IRON- prenatal with ferrous fumarate and folic acid tablet

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

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Updated May 23, 2023

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  • DESCRIPTION

    Supplement Facts
    Serving Size: 1 TabletAmount per Serving% Daily Value*
    *
    Daily Value is for Pregnant and Lactating Women
    Vitamin A1200 mcg92%
    (Acetate and Beta Carotene)RAE
    Vitamin C (Ascorbic Acid)120 mg100%
    Vitamin D-3 (Cholecalciferol)10 mcg67%
    Vitamin E (dl-α Tocopheryl Acetate)10 mg53%
    Vitamin B-1 (Thiamine Mononitrate)1.84 mg131%
    Vitamin B-2 (Riboflavin)3 mg188%
    Niacin (Niacinamide)20 mg111%
    Vitamin B-6 (Pyridoxine HCl)10 mg500%
    Folic Acid1667 mcg278%
    DFE (1 mg)
    Vitamin B-12 (Cyanocobalamin)12 mcg429%
    Calcium (Calcium Carbonate)200 mg15%
    Iron (Ferrous Fumarate)27 mg100%
    Zinc (Zinc Oxide)25 mg192%
    Copper(Cupric Oxide)2 mg154%

    Other Ingredients: Hypromellose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Stearic Acid, Titanium Dioxide, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow #6 lake

  • Description

    Prenatal Plus Vitamins is a prescription folic acid containing dietary vitamin and mineral supplement for women before, during and after pregnancy.

  • Directions

    Use before, during and after pregnancy under the supervision of a medical professional. One tablet daily or as prescribed.

  • Caution

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

  • BOXED WARNING (What is this?)

    WARNING

    Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. Keep this product out of the reach of children. In case of accidental overdose, call a Physician or Poison Control Center immediately.

  • Storage

    Store at room temperature, USP. Protect from light and moisture. Dispense in a tight, light-resistant container. Contact with moisture may discolor or erode tablets.

  • SPL UNCLASSIFIED SECTION

    Manufactured for Patrin Pharma
    Skokie, IL 60076
    Call (800) 936 3088

    Rev 02.1120
    Lot/Exp Date

  • HOW SUPPLIED

    Product: 50090-0616

    NDC: 50090-0616-0 100 TABLET in a BOTTLE, PLASTIC

    NDC: 50090-0616-1 30 TABLET in a BOTTLE

  • Prenatal with Ferrous Fum and Folic Acid

    Label Image
  • INGREDIENTS AND APPEARANCE
    PRENATAL VITAMINS PLUS LOW IRON 
    prenatal with ferrous fumarate and folic acid tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50090-0616(NDC:39328-106)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A924 ug
    .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE276 ug
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-10 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 ACID1667 ug
    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
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
    Inactive Ingredients
    Ingredient NameStrength
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    FD&C Blue NO. 2 (UNII: L06K8R7DQK)  
    FD&C Red NO. 40 (UNII: WZB9127XOA)  
    FD&C Yellow NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorBROWN (Beige) Scoreno score
    ShapeOVAL (OVAL) Size9mm
    FlavorImprint Code P;5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-0616-0100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/2014
    2NDC:50090-0616-130 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER04/01/2013
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-0616) , REPACK(50090-0616)
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