MedPath

IROSPAN 24/6

Irospan 24/6

Approved
Approval ID

0722734e-5a30-47af-99a3-2512848b45cd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 18, 2023

Manufacturers
FDA

WOMENS CHOICE PHARMACEUTICALS LLC

DUNS: 833067841

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

IRON, FOLIC ACID, VITAMIN/MINERAL SUPPLEMENT

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50967-126
Product Classification
G
Generic Name
IRON, FOLIC ACID, VITAMIN/MINERAL SUPPLEMENT
Product Specifications
Effective DateJanuary 18, 2023
FDA Product Classification

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/15/2011

IROSPAN 24/6 CARTON LABELING

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 4/15/2011

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/15/2011

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 SECTION

LOINC: 34069-5Updated: 4/15/2011

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)

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 11/3/2019

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IROSPAN 24/6 - FDA Drug Approval Details