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

  • NDC Code(s): 39328-106-10, 39328-106-50
  • Packager: Patrin Pharma, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated January 13, 2022

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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

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    Rx
    Only

    NDC 39328-106-10

    Prenatal Plus
    Vitamins

    27 mg Fe & 1 mg FA

    Before, During and After
    Pregnancy

    100 tablets
    Made in the USA

    PATRIN
    PHARMA

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    PRENATAL PLUS VITAMINS 
    prenatal with ferrous fumarate and folic acid tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)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:39328-106-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2013
    2NDC:39328-106-50500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/201311/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER04/01/2013
    Labeler - Patrin Pharma, Inc. (806841677)
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