NDC | 50967-126-30 |
Set ID | 0722734e-5a30-47af-99a3-2512848b45cd |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | WOMENS CHOICE PHARMACEUTICALS LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- DESCRIPTION
-
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.
- INDICATIONS & USAGE
-
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.
- BOXED WARNING (What is this?)
-
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.
- ADVERSE REACTIONS
-
Dosage and Administration
Usual adult dosage is 1 tablet daily or as directed by a physician. The IROSPAN® carton contains a 30 day course of iron therapy that consists of 24 light blue tablets and 6 white tablets. Take 1 light blue tablet daily for 24 days, followed by 1 white tablet daily for 6 days. After the 30 tablets have been taken, a new course may be started if prescribed.
- How Supplied
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
IROSPAN 24/6
iron, folic acid, vitamin/mineral supplement kitProduct 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 6 Part 1 of 2 IROSPAN 24/6
iron, multi-vitamin mineral supplement tabletProduct 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 coatedProduct 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)