Prednisolone Acetate (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 Prednisolone Acetate Ophthalmic Suspension USP, 1% 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

Prednisolone Acetate Ophthalmic Suspension USP, 1% 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.

5mL — NDC 54868-4293-2

10mL — NDC 54868-4293-1

15mL — NDC 54868-4293-0

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

Rx Only

Revised: November 2007

*DROP-TAINER is a registered trademark

of Alcon Manufacturing, Ltd.

Dist. by:

FALCON Pharmaceuticals Ltd.

Fort Worth, Texas 76134 USA

Mfd. by:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

Printed in USA

9003146-1007

Distributed by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

PRINCIPAL DISPLAY PANEL

NDC 54868-4293-1


carton
(click image for full-size original)

Rx Only

Prednisolone

Acetate

Ophthalmic

Suspension USP

1%

10 mL STERILE

PREDNISOLONE ACETATE
prednisolone acetate suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4293(NDC:61314-637)
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
HYPROMELLOSES
SODIUM PHOSPHATE, DIBASIC
POLYSORBATE 80
EDETATE DISODIUM
GLYCERIN
CITRIC ACID MONOHYDRATE
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4293-2 1 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
1 5 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54868-4293-2)
2 NDC:54868-4293-1 1 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
2 10 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54868-4293-1)
3 NDC:54868-4293-0 1 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
3 15 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54868-4293-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA017469 11/04/2002
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel (54868-4293)

Revised: 10/2012 Physicians Total Care, Inc.

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