Label: IROSPAN 24/6- iron, folic acid, vitamin/mineral supplement

  • NDC Code(s): 50967-126-30
  • Packager: WOMENS CHOICE PHARMACEUTICALS LLC
  • 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 December 5, 2018

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

  • BOXED WARNING(What is this?)

    WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

    Close
  • DESCRIPTION

    IROSPAN TABLET DESCRIPTION :   Each light blue capsule-shaped film coated tablet has a pleasant sweet flavor with WC002 imprinted on one side.

    SUCCINIC ACID TABLET DESCRIPTION: Each white round film coated tablet has a pleasant sweet flavor with WC imprinted on one side.

    Close
  • CLINICAL PHARMACOLOGY

    Clinical Pharmacology : Iron is an essential component in the formation of hemoglobin.  Adequate amounts of iron are necessary for effective erthropoiesis.  Iron also serves as a cofactor of several essential enzymes, including cytochromes that are involved in electron transport.


    Folic acid is required for nucleoprotein synthesis and the maintenance of normal erthropoiesis.  Folic acid is converted in the liver and plasma to its metabolically active form, tetrahydrofolic acid, by dihydrofolate reductase.


    Vitamin B12 is required for the maintenance of normal erthropoiesis, nucleprotein and myelin synthesis, cell reproduction and normal growth.  Intrinsic factor, a glycoprotein secreted by the gastric mucosa, is required for active absorption of Vitamin B12 from the gastrointestinal tract.

    Close
  • INDICATIONS & USAGE

    INDICATION AND USAGE: IROSPAN 24/6 is indicated for the treatment of all anemias that are responsive to oral iron therapy.  These include: hypochromic anemia associated with pregnancy, chronic and/or acute blood loss, metabolic disease, post-surgical convalescence, and dietary needs.

    Close
  • CONTRAINDICATIONS

    Warnings: Ingestion of more than 3 grams of omega-fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.



    Close
  • PRECAUTIONS

    P recautions:  Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. This product contains formate, which if consumed above the recommended level, could cause visual impairment and other health effects. Do not take more than the recommended amount. If you are pregnant, nursing, or taking any medications consult your doctor before use. Discontinue use and consult your doctor if any adverse reactions occur. Not intended for use by persons under the age of 18.

    Close
  • ADVERSE REACTIONS

    A dverse Reactions:  Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

    Close
  • DOSAGE & ADMINISTRATION

    D osage and Administration: Nestabs DHA - One tablet and one soft gel capsule daily or as directed by a physician.

    Close
  • HOW SUPPLIED

    H ow Supplied:  Nestabs DHA tablets for oral administration are supplied as six child-resistant blister cards containing 5 tablets and 5 softgel capsules each (NDC# 50967-317-30).

    Close
  • INGREDIENTS AND APPEARANCE
    IROSPAN 24/6 
    iron, folic acid, vitamin/mineral supplement kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50967-126
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50967-126-30 4 in 1 CARTON 04/15/2011
    1 1 in 1 BLISTER PACK
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 24 
    Part 2
    Part 1 of 2
    IROSPAN 24/6 
    iron, multi-vitamin mineral supplement tablet
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 100 mg
    CALCIUM FORMATE (UNII: NP3JD65NPY) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 155 mg
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE 5 mg
    RIBOFLAVIN SODIUM (UNII: 04SRR95RP8) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN SODIUM 5 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 25 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 30 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 10 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 300 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 300 ug
    FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 65 mg
    IRON DEXTRAN (UNII: 95HR524N2M) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SACCHARIN (UNII: FST467XS7D)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Product Characteristics
    Color blue Score no score
    Shape OVAL Size 18mm
    Flavor Imprint Code WC;002
    Contains     
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 04/15/2011
    Part 2 of 2
    IROSPAN SUCCINIC ACID 
    succinic acid with multi-vitamin/mineral supplement tablet, film coated
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 100 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 100 mg
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE 5 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 5 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 25 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 30 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 10 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 300 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 7 mg
    SUCCINIC ACID (UNII: AB6MNQ6J6L) (SUCCINIC ACID - UNII:AB6MNQ6J6L) SUCCINIC ACID 150 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    SACCHARIN (UNII: FST467XS7D)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code WC;
    Contains     
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 04/15/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 04/15/2011
    Labeler - WOMENS CHOICE PHARMACEUTICALS LLC (833067841)
    Registrant - WOMENS CHOICE PHARMACEUTICALS LLC (833067841)
    Close