Irospan 24/6

Generic Name: iron, folic acid, vitamin/mineral
Dosage Form: capsules/tablets kit

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.

Irospan 24/6

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.

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.

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.

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.



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.

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

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

How 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).

Irospan 24/6 
iron, folic acid, vitamin/mineral supplement kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50967-126
Packaging
# Item Code Package Description
1 NDC:50967-126-30 4 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 1 KIT (KIT) 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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM ASCORBATE (ASCORBIC ACID) ASCORBIC ACID 100 mg
CALCIUM FORMATE (CALCIUM) CALCIUM 155 mg
THIAMINE HYDROCHLORIDE (THIAMINE) THIAMINE 5 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 5 mg
NIACIN (NIACIN) NIACIN 25 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 30 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 10 ug
BIOTIN (BIOTIN) BIOTIN 300 ug
CALCIUM PANTOTHENATE (CALCIUM PANTOTHENATE) CALCIUM PANTOTHENATE 300 ug
FERROUS BISGLYCINATE (IRON) IRON 65 mg
IRON DEXTRAN (IRON) IRON 65 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
MAGNESIUM STEARATE  
POVIDONE  
POLYVINYL ALCOHOL  
POLYETHYLENE GLYCOL 3350  
TITANIUM DIOXIDE  
TALC  
FD&C BLUE NO. 1  
SACCHARIN  
CARNAUBA WAX  
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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM ASCORBATE (ASCORBIC ACID) ASCORBIC ACID 100 mg
CALCIUM CARBONATE (CARBONATE ION) CARBONATE ION 100 mg
THIAMINE HYDROCHLORIDE (THIAMINE) THIAMINE 5 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 5 mg
NIACIN (NIACIN) NIACIN 25 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 30 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 10 ug
BIOTIN (BIOTIN) BIOTIN 300 ug
CALCIUM PANTOTHENATE (PANTOTHENIC ACID) PANTOTHENIC ACID 7 mg
SUCCINIC ACID (SUCCINIC ACID) SUCCINIC ACID 150 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
MAGNESIUM STEARATE  
POVIDONE  
POLYVINYL ALCOHOL  
POLYETHYLENE GLYCOL 3350  
TITANIUM DIOXIDE  
TALC  
SACCHARIN  
CARNAUBA WAX  
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)
Revised: 04/2011
 
WOMENS CHOICE PHARMACEUTICALS LLC



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