Label: PRENATAL PLUS- vitamin a, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, zinc oxide, and cupric oxide tablet

  • NDC Code(s): 42937-705-10, 42937-705-16, 42937-705-18
  • Packager: Nationwide Laboratories
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 4, 2020

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  • DESCRIPTION

    Each Tablet Contains:
    VITAMINS:
    Amount per Tablet
    Vitamin A (from Acetate and Beta Carotene)4000 IU
    Vitamin C (Ascorbic Acid)120 mg
    Vitamin D-3 (Cholecalciferol)400 IU
    Vitamin E (dl-Alpha Tocopheryl Acetate)22 IU
    Thiamine (Vitamin B-1 from Thiamine Mononitrate)1.84 mg
    Riboflavin (Vitamin B-2)3 mg
    Niacin (as Niacinamide)20 mg
    Vitamin B-6 (from Pyridoxine HCl)10 mg
    Folic Acid1 mg
    Vitamin B-12 (Cyanocobalamin)12 mcg
    MINERALS:
    Calcium (from Calcium Carbonate)200 mg
    Iron (from Carbonyl Iron)29 mg
    Zinc (from Zinc Oxide)25 mg
    Copper (from 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 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.

  • Indication

    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 physician.

  • BOXED WARNING (What is this?)

    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 progresses.

    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 Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

  • STORAGE AND HANDLING

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

  • SPL UNCLASSIFIED SECTION

    CALL YOUR DOCTOR FOR MEDICAL ADVISE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 (TOLL FREE).

    Keep this and all medication out of the reach of children.

    Do not use if imprinted Safety Seal under cap is broken or missing.

    Distributed by: Nationwide Laboratories, Iselin NJ 08830

    Lot No.: Exp. Date: Rev. 7/12

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    Nationwide Laboratories LLC

    NDC 42937-705-10

    Prenatal Plus
    Iron Tablets

    Multivitamin/Multimineral
    Supplement

    For Use Before, During
    and After Pregnancy.

    Rx only

    100 Tablets

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    PRENATAL PLUS 
    vitamin a, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, zinc oxide, and cupric oxide tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42937-705
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Vitamin A (UNII: 81G40H8B0T) (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, 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) 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, Carbonate Ion - UNII:7UJQ5OPE7D) Calcium Carbonate200 mg
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron29 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
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Anhydrous Citric Acid (UNII: XF417D3PSL)  
    .Alpha.-Tocopherol, Dl- (UNII: 7QWA1RIO01)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    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)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    Acacia (UNII: 5C5403N26O)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Mineral Oil (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (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
    ColorYELLOW (Tan) Scoreno score
    ShapeOVALSize18mm
    FlavorImprint Code CIS;28
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42937-705-10100 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
    2NDC:42937-705-16250 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
    3NDC:42937-705-18500 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER06/01/2011
    Labeler - Nationwide Laboratories (078366153)