MedPath
FDA Approval

IROSPAN 24/6

January 18, 2023

HUMAN PRESCRIPTION DRUG LABEL

Registrants (1)

Products (1)

IROSPAN 24/6

50967-126

January 18, 2023

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IROSPAN 24/6 CARTON LABELING


RECENT MAJOR CHANGES SECTION


DOSAGE & ADMINISTRATION SECTION

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.


ADVERSE REACTIONS SECTION

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


HOW SUPPLIED SECTION

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)


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