The following Structured Product Label (SPL) was submitted to the FDA by Womens Choice Pharmaceuticals Llc for the product Irospan 24/6 (NDC 50967-126). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, clinical pharmacology, indications & usage, contraindications, boxed warning, precautions, adverse reactions, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
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 Carton Labeling (Irospancarton)
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