FACTIVE (Page 12 of 12)

What are the ingredients in Factive?

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

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

Revised October 2011
© Cornerstone Therapeutics Inc. 2011
FACTIVE is a registered trademark of LG Life Sciences.

Manufactured for:
Cornerstone Therapeutics Inc. Cary, NC 27518

Licensed from LG Life Sciences, Ltd. Seoul, Korea

CTF-005-0811-01-SPL

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:10122-321
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:10122-321-05 5 TABLET (5 TABLET) in 1 BLISTER PACK None
2 NDC:10122-321-07 7 TABLET (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 — Cornerstone Therapeutics Inc. (088084228)

Revised: 11/2011 Cornerstone Therapeutics Inc.

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