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Gemifloxacin how supplied

Introduction

Gemifloxacin mesylate
FACTIVE® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages
HOW SUPPLIED

HOW SUPPLIED

FACTIVE (gemifloxacin mesylate) is available as white to off-white, oval, film-coated tablets with breaklines and GE 320 debossed on both faces. Each tablet contains gemifloxacin mesylate equivalent to 320 mg of gemifloxacin.

320 mg Unit of Use (CR*) 5’s NDC 67707-320-05 320 mg Unit of Use (CR*) 7’s NDC 67707-320-07

  • Child Resistant

Storage

Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF) [see USP Controlled Room Temperature]. Protect from light.

References

References

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021158s013lbl.pdf

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]