FACTIVE: Package Insert and Label Information (Page 7 of 7)

How should I store FACTIVE?

  • Store FACTIVE at room temperature between 59º — 86ºF (15º to 30ºC).
  • Keep FACTIVE away from light.

Keep FACTIVE and all medicines out of the reach of children.

General Information about FACTIVE

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FACTIVE for a condition for which it is not prescribed. Do not give FACTIVE to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about FACTIVE. If you would like more information about FACTIVE, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about FACTIVE that is written for healthcare professionals. For more information go to www.FACTIVE.com or call 1-888-431-4276.

What are the ingredients in Factive?

  • Active ingredient: gemifloxacin
  • Inactive ingredients: crospovidone, hydroxypropyl methycellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.

© Merus Labs International Inc.
FACTIVE is a registered trademark of LG Life Sciences.

Manufactured for:
merus-labsToronto, ON M5K 1H1 Canada

Licensed from LG Life Sciences, Ltd. Seoul, Korea

MRS-001-0313-03

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised 07/2016

Factive 5 Tablets
(click image for full-size original)

Factive 5 Tablets

Factive 7 Tablets
(click image for full-size original)

Factive 7 Tablets

FACTIVE gemifloxacin mesylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44001-321
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GEMIFLOXACIN MESYLATE (GEMIFLOXACIN) GEMIFLOXACIN 320 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (15 MPA.S)
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 4000
POLYETHYLENE GLYCOL 6000
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape OVAL Size 16mm
Flavor Imprint Code GE;320
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44001-321-05 5 TABLET in 1 BLISTER PACK None
2 NDC:44001-321-07 7 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021158 04/04/2003
Labeler — Merus Labs International Inc. (244172404)
Establishment
Name Address ID/FEI Operations
Patheon Inc. 005286822 manufacture (44001-321)

Revised: 08/2016 Merus Labs International Inc.

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