Prednisolone Ophthalmic Suspension

Name: Prednisolone Ophthalmic Suspension

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 61314-637-05

10mL - NDC 61314-637-10

15mL - NDC 61314-637-15

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

Rx Only

Revised: November 2011

*DROP-TAINER is a registered trademark
of Alcon Research, Ltd.

SANDOZ

Manufactured by
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 for
Sandoz Inc.
Princeton, NJ 08540
Printed in USA

9007312-1111

Principal display panel

NDC 61314-637-10

Prednisolone Acetate Ophthalmic Suspension USP 1%

Rx only

STERILE
10 mL

SANDOZ

FOR TOPICAL OPHTHALMIC USE ONLY.

INGREDIENTS: Each mL contains:
Active: prednisolone acetate 1.0%.
Preservative: benzalkonium chloride 0.01%.
Vehicle: hypromellose.
Inactives: dibasic sodium phosphate, polysorbate 80, edetate disodium, glycerin, citric acid and/or sodium hydroxide (to adjust pH), purified water.

USUAL DOSAGE: Two drops topically in the eye(s) four times daily.

PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the suspension.

Read enclosed insert.

SHAKE WELL BEFORE USING.

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

MANUFACTURED BY ALCON LABORATORIES, INC.

Manufactured by
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 for
Sandoz Inc.
Princeton, NJ 08540
Printed in USA

9007318-1111

LOT:

EXP.:

NDC 61314-637-10

Prednisolone Acetate Ophthalmic Suspension USP 1%

Rx only

STERILE
10 mL

SANDOZ

FOR TOPICAL OPHTHALMIC USE ONLY.

INGREDIENTS: Each mL contains:
Active: prednisolone acetate 1.0%.
Preservative: benzalkonium chloride 0.01%.
Vehicle: hypromellose.
Inactives: dibasic sodium phosphate, polysorbate 80, edetate disodium, glycerin, citric acid and/or sodium hydroxide (to adjust pH), purified water.

USUAL DOSAGE: Two drops topically in the eye(s) four times daily.

WARNING: Do not touch dropper tip to any surface, as this may contaminate the suspension.

Read enclosed insert.

SHAKE WELL BEFORE USING.

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

Manufactured by
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 for
Sandoz Inc.
Princeton, NJ 08540
Printed in USA

H13438-0214

LOT/EXP.:

PREDNISOLONE ACETATE  
prednisolone acetate suspension/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) 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
1 NDC:61314-637-05 1 BOTTLE, PLASTIC in 1 CARTON
1 5 mL in 1 BOTTLE, PLASTIC
2 NDC:61314-637-10 1 BOTTLE, PLASTIC in 1 CARTON
2 10 mL in 1 BOTTLE, PLASTIC
3 NDC:61314-637-15 1 BOTTLE, PLASTIC in 1 CARTON
3 15 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA017469 12/15/1994
Labeler - Sandoz Inc. (005387188)
Registrant - Alcon Laboratories, Inc. (008018525)
Establishment
Name Address ID/FEI Operations
Alcon Research Ltd 007672236 manufacture(61314-637)
Revised: 01/2016   Sandoz Inc.

Highlights for prednisolone

PREDNISOLONE (pred NISS oh lone) is a corticosteroid. It is used to treat swelling, redness, itching, and allergic reactions in the eye.

This drug also comes in other forms, including Ophthalmic solution, Oral syrup, Oral solution, Orally disintegrating solid, Oral tablet, ... more

This drug can cause serious side effects. See which side effects you should report to your doctor right away.

Know how to use your medication, and learn what might happen if you miss a dose.

Talk to your healthcare provider if you have any of these conditions.

Know what to watch for and get tips for reducing your risks while taking this drug.

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