Label: PRENATAL VITAMINS PLUS LOW IRON- prenatal with ferrous fum 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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 25, 2013

If you are a consumer or patient please visit this version.

  • BOXED WARNING (What is this?)

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

  • DESCRIPTION

    Each Tablet Contains:Amount
    Per Tablet
    % Daily
    Value
    Vitamin A (from Acetate and Beta Carotene)4000 IU80%
    Vitamin C (Ascorbic Acid)120 mg200%
    Vitamin D-3 (Cholecalciferol)400 IU100%
    Vitamin E (dl-Alpha Tocopheryl Acetate)22 mg73%
    Vitamin B-1(Thiamine Mononitrate)1.84 mg123%
    Vitamin B-2 (Riboflavin)3 mg176%
    Niacin (as Niacinamide)20 mg100%
    Vitamin B-6 (Pyridoxine HCI)10 mg500%
    Folic Acid1 mg200%
    Vitamin B-12 (Cyanocobalamin)12 mcg200%
    Calcium (from Calcium Carbonate)200 mg20%
    Iron (Ferrous Fumarate)27 mg150%
    Zinc (Zinc Oxide)25mg167%
    Copper (Cupric Oxide)2 mg100%

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

  • INDICATIONS & USAGE

    Indications: To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and nonlactating mother. It is also useful for improving nutritional status prior to conception.

  • DOSAGE & ADMINISTRATION

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

  • CONTRAINDICATIONS

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

  • PRECAUTIONS

    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 REACH OF CHILDREN. In case of accidental overdose, call a physician or Poison Control Center immediately.

  • STORAGE AND HANDLING

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

  • HOW SUPPLIED

    Manufactured in USA for: Patrin Pharma, Inc.
    Skokie, IL 60076 800-936-3088
    Rev 01.0313

  • PRINCIPAL DISPLAY PANEL

    PRENATAL VITAMIN PLUS LOW IRON TABLETS - 100 TABLETS
    PRENATAL VITAMIN PLUS LOW IRON TABLETS - 500 TABLETS
  • INGREDIENTS AND APPEARANCE
    PRENATAL VITAMINS PLUS LOW IRON 
    prenatal with ferrous fum 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 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 mg
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.84 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE10 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
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON27 mg
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC25 mg
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER2 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    ACACIA (UNII: 5C5403N26O)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLCELLULOSE (100 MPA.S) (UNII: 4GFU244C4J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBIC ACID (UNII: X045WJ989B)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    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
    2NDC:39328-106-50500 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other04/01/2013
    Labeler - Patrin Pharma, Inc. (806841677)
    Registrant - Patrin Pharma, Inc. (806841677)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patrin Pharma, Inc.806841677MANUFACTURE(39328-106)