Irospan 24/6
Iron, Folic Acid, Vitamin/mineral Supplement
Womens Choice Pharmaceuticals Llc
Human Prescription Drug
NDC 50967-126Irospan 24/6 also known as Iron, Folic Acid, Vitamin/mineral Supplement is a human prescription drug labeled by 'Womens Choice Pharmaceuticals Llc'. National Drug Code (NDC) number for Irospan 24/6 is 50967-126. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Irospan 24/6 drug includes . The currest status of Irospan 24/6 drug is Active.
Drug Information:
| Drug NDC: | 50967-126 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Irospan 24/6 |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Iron, Folic Acid, Vitamin/mineral Supplement |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Womens Choice Pharmaceuticals Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 15 Apr, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | WOMENS CHOICE PHARMACEUTICALS LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1102201
1102202
1102206
1102207
1102196
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 50967-126-30 | 4 BLISTER PACK in 1 CARTON (50967-126-30) / 1 KIT in 1 BLISTER PACK | 15 Apr, 2011 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Irospan 24/6 iron, folic acid, vitamin/mineral supplement irospan 24/6 iron, multi-vitamin mineral supplement cellulose, microcrystalline magnesium stearate povidone polyvinyl alcohol polyethylene glycol 3350 titanium dioxide talc fd&c blue no. 1 saccharin carnauba wax sodium ascorbate ascorbic acid calcium formate calcium cation thiamine hydrochloride thiamine ion riboflavin sodium riboflavin niacin niacin pyridoxine hydrochloride pyridoxine folic acid folic acid cyanocobalamin cyanocobalamin biotin biotin calcium pantothenate calcium cation ferrous bisglycinate ferrous cation iron dextran ferric cation wc;002 irospan succinic acid succinic acid with multi-vitamin/mineral supplement cellulose, microcrystalline magnesium stearate povidone polyvinyl alcohol polyethylene glycol 3350 titanium dioxide talc saccharin carnauba wax sodium ascorbate ascorbic acid calcium carbonate carbonate ion thiamine hydrochloride thiamine ion riboflavin riboflavin niacin niacin pyridoxine hydrochloride pyridoxine folic acid folic acid cyanocobalamin cyanocobalamin biotin biotin calcium pantothenate pantothenic acid succinic acid succinic acid wc;
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.
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:
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.
Adverse Reactions:
A dverse reactions: allergic sensitization has been reported following both oral and parenteral administration of folic acid.
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.
How Supplied:
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)
Package Label Principal Display Panel:
Irospan 24/6 carton labeling