NDC 50967-126 Irospan 24/6

Iron, Folic Acid, Vitamin/mineral Supplement

NDC Product Code 50967-126

NDC CODE: 50967-126

Proprietary Name: Irospan 24/6 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Iron, Folic Acid, Vitamin/mineral Supplement What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
BLUE (C48333)
WHITE (C48325)
Shape: OVAL (C48345)
ROUND (C48348)
Size(s):
18 MM
6 MM
Imprint(s):
WC;002
WC;
Score: 1

NDC Code Structure

  • 50967 - Womens Choice Pharmaceuticals Llc

NDC 50967-126-30

Package Description: 4 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK

Price per Unit: $4.38347 per EA

NDC Product Information

Irospan 24/6 with NDC 50967-126 is a a human prescription drug product labeled by Womens Choice Pharmaceuticals Llc. The generic name of Irospan 24/6 is iron, folic acid, vitamin/mineral supplement. The product's dosage form is kit and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1102196, 1102201, 1102202, 1102206 and 1102207.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)
  • 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 Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Womens Choice Pharmaceuticals Llc
Labeler Code: 50967
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-15-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Irospan 24/6 Product Label Images

Irospan 24/6 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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.

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

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

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

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

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

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

Dosage & Administration

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

How Supplied

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).

* Please review the disclaimer below.