Wednesday, September 21, 2016

Irospan 24/6




Generic Name: iron, folic acid, vitamin/mineral

Dosage Form: capsules/tablets kit
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 TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)50967-126














Packaging
#NDCPackage DescriptionMultilevel Packaging
150967-126-304 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
11 KIT In 1 BLISTER PACKThis package is contained within the CARTON (50967-126-30)











QUANTITY OF PARTS
Part #Package QuantityTotal Product Quantity
Part 1 24 
Part 2 



Part 1 of 2
Irospan 24/6  
iron, multi-vitamin mineral supplement  tablet










Product Information
   
Route of AdministrationORALDEA Schedule    









































Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM ASCORBATE (ASCORBIC ACID)ASCORBIC ACID100 mg
CALCIUM FORMATE (CALCIUM)CALCIUM155 mg
THIAMINE HYDROCHLORIDE (THIAMINE)THIAMINE5 mg
RIBOFLAVIN (RIBOFLAVIN)RIBOFLAVIN5 mg
NIACIN (NIACIN)NIACIN25 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE)PYRIDOXINE30 mg
FOLIC ACID (FOLIC ACID)FOLIC ACID1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN)CYANOCOBALAMIN10 ug
BIOTIN (BIOTIN)BIOTIN300 ug
CALCIUM PANTOTHENATE (CALCIUM PANTOTHENATE)CALCIUM PANTOTHENATE300 ug
FERROUS BISGLYCINATE (IRON)IRON65 mg
IRON DEXTRAN (IRON)IRON65 mg
























Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
MAGNESIUM STEARATE 
POVIDONE 
POLYVINYL ALCOHOL 
POLYETHYLENE GLYCOL 3350 
TITANIUM DIOXIDE 
TALC 
FD&C BLUE NO. 1 
SACCHARIN 
CARNAUBA WAX 


















Product Characteristics
ColorblueScoreno score
ShapeOVALSize18mm
FlavorImprint CodeWC;002
Contains      







Packaging
#NDCPackage DescriptionMultilevel Packaging
Package Information Not Applicable










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/15/2011




Part 2 of 2
IROSPAN SUCCINIC ACID  
succinic acid with multi-vitamin/mineral supplement  tablet, film coated










Product Information
   
Route of AdministrationORALDEA Schedule    






































Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM ASCORBATE (ASCORBIC ACID)ASCORBIC ACID100 mg
CALCIUM CARBONATE (CARBONATE ION)CARBONATE ION100 mg
THIAMINE HYDROCHLORIDE (THIAMINE)THIAMINE5 mg
RIBOFLAVIN (RIBOFLAVIN)RIBOFLAVIN5 mg
NIACIN (NIACIN)NIACIN25 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE)PYRIDOXINE30 mg
FOLIC ACID (FOLIC ACID)FOLIC ACID1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN)CYANOCOBALAMIN10 ug
BIOTIN (BIOTIN)BIOTIN300 ug
CALCIUM PANTOTHENATE (PANTOTHENIC ACID)PANTOTHENIC ACID7 mg
SUCCINIC ACID (SUCCINIC ACID)SUCCINIC ACID150 mg






















Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
MAGNESIUM STEARATE 
POVIDONE 
POLYVINYL ALCOHOL 
POLYETHYLENE GLYCOL 3350 
TITANIUM DIOXIDE 
TALC 
SACCHARIN 
CARNAUBA WAX 


















Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize6mm
FlavorImprint CodeWC;
Contains      







Packaging
#NDCPackage DescriptionMultilevel Packaging
Package Information Not Applicable










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/15/2011











Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/15/2011


Labeler - WOMENS CHOICE PHARMACEUTICALS LLC (833067841)

Registrant - WOMENS CHOICE PHARMACEUTICALS LLC (833067841)
Revised: 04/2011WOMENS CHOICE PHARMACEUTICALS LLC



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