Irospan 24/6

Irospan 24/6
SPL v8
SPL
SPL Set ID 0722734e-5a30-47af-99a3-2512848b45cd
Route
ORAL
Published
Effective Date 2011-04-15
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ascorbic Acid (100 mg) Calcium Cation (155 mg) Thiamine Ion (5 mg) Riboflavin (25 mg) Niacin (30 mg) Pyridoxine (1 mg) Folic Acid (10 ug) Cyanocobalamin (65 mg) Ferric Cation (300 ug) Biotin (7 mg) Ferrous Cation (150 mg) Carbonate Ion Pantothenic Acid Succinic Acid
Inactive Ingredients
Cellulose, Microcrystalline Magnesium Stearate Povidone Polyvinyl Alcohol Polyethylene Glycol 3350 Titanium Dioxide Talc Fd&c Blue No. 1 Saccharin Carnauba Wax

Identifiers & Packaging

Pill Appearance
Imprint: WC; Shape: oval Shape: round Color: blue Color: white Size: 18 mm Size: 6 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2011-04-15

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.

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

IROSPAN® 24/6 tablets for oral administration are available in four child resistant blister cards containing 30 tablets (24 light blue tablets and 6 white tablets) (NDC 50967-126-30)


Medication Information

Recent Major Changes

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.

Indications and 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.

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.

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.





How Supplied

IROSPAN® 24/6 tablets for oral administration are available in four child resistant blister cards containing 30 tablets (24 light blue tablets and 6 white tablets) (NDC 50967-126-30)

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.

Section 34084-4

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

Section 34090-1

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.

Section 42232-9

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.

Section 51945-4


Structured Label Content

Recent Major Changes (34066-1)

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.

Indications and Usage (34067-9)

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.

Contraindications (34070-3)

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.





Section 34084-4 (34084-4)

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

Description (34089-3)

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.

Section 34090-1 (34090-1)

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.

Section 42232-9 (42232-9)

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.

Section 51945-4 (51945-4)

How Supplied

IROSPAN® 24/6 tablets for oral administration are available in four child resistant blister cards containing 30 tablets (24 light blue tablets and 6 white tablets) (NDC 50967-126-30)

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.


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