OMNIPRED (Page 2 of 2)

DOSAGE AND ADMINISTRATION

SHAKE WELL BEFORE USING. Two drops topically in the eye(s) four times daily. In cases of bacterial infections, concomitant use of anti-infective agents is mandatory. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (SEE PRECAUTIONS).

The dosing of OMNIPRED® suspension may be reduced, but care should be taken not to discontinue therapy prematurely.

In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.

HOW SUPPLIED

OMNIPRED® (prednisolone acetate ophthalmic suspension) is supplied in a white, round low density polyethylene DROP-TAINER® dispenser with a natural low density polyethylene dispensing plug and pink polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.

OMNIPRED® suspension:

5 mL NDC 0065-0638-27

10 mL NDC 0065-0638-25

STORAGE: STORE at 8° — 24°C (46° — 75°F) in an UPRIGHT position.

Rx Only

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

Printed in USA

©2006-2008 Alcon, Inc.

Revised: October 2007

9004078-1008

PRINCIPAL DISPLAY PANEL

NDC 0065-0638-25
STERILE

Omni pred ®
(prednisolone acetate ophthalmic suspension) 1%
10 mL
Alcon ®

PRINCIPAL DISPLAY PANEL -- NDC 0065-0638-25 Omnipred® (prednisolone acetate ophthalmic suspension) 1%
								10 mL Alcon®
(click image for full-size original)
OMNIPRED
prednisolone acetate suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0065-0638
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREDNISOLONE ACETATE (PREDNISOLONE) PREDNISOLONE ACETATE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
POLYSORBATE 80
EDETATE DISODIUM
GLYCERIN
CITRIC ACID MONOHYDRATE
SODIUM HYDROXIDE
WATER
HYPROMELLOSES
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0065-0638-27 5 mL in 1 BOTTLE, PLASTIC None
2 NDC:0065-0638-25 10 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017469 11/06/2007 05/31/2021
Labeler — Alcon Laboratories, Inc. (008018525)

Revised: 06/2020 Alcon Laboratories, Inc.

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