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Bromfenac (Bromday, Bromsite): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
0.75 mg/mL
Brand names:
Active ingredient:

Patient information: uses, side effects, how to take - Bromfenac

INSTRUCTIONS FOR USE

Bromfenac (brome' fen ak ) Ophthalmic Solution

0.075%

Read this Instructions for Use before you start using bromfenac ophthalmic solution and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

Information about bromfenac ophthalmic solution:

  • Do not let the bromfenac ophthalmic solution nozzle touch your eye, fingers, or any other surfaces.
  • If you are using bromfenac ophthalmic solution with other eye (ophthalmic) medicines, you should wait at least 5 minutes after using the other medicine to give your bromfenac ophthalmic solution dose.
  • You should not wear contact lenses while using bromfenac ophthalmic solution.
  • Put the gray cap back on the bromfenac ophthalmic solution after each use.

Before you use bromfenac ophthalmic solution for the first time:

  • Break the tamper evident ring by turning cap in counterclockwise direction (See FIGURE A).
  • Hold the bottle upright. Remove the gray cap by turning it in the counterclockwise direction (See FIGURE B).
  • Replace the gray cap on the bottle and close tightly (See FIGURE C).

Follow Steps 1 to 5 each time you use bromfenac ophthalmic solution.

Step 1. Wash your hands well.

Step 2. Turn the closed bottle upside down (See FIGURE D).

Step 3. Flick bottle firmly 1 time before each use to move the medicine into the tip of the bottle (See FIGURE E).

Step 4. Keep the bottle upside down and remove the gray cap by turning it in clockwise direction (See FIGURE F).

Step 5. Tilt your head back. Gently squeeze the bottle to place 1 drop into the affected eye (See FIGURE G). Replace the gray cap on the bottle and close tightly.

How do I store bromfenac ophthalmic solution?

  • Store bromfenac ophthalmic solution at 15°C to 25°C (59°F to 77°F). After opening, bromfenac ophthalmic solution can be used until the expiration date on the bottle.
  • Throw away the bromfenac ophthalmic solution bottle after your treatment is finished.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Naples, FL 34108

United States

Manufactured by:

Lupin Limited

Pithampur (M.P.) - 454 775

India

Revised: October 2024 ID #277250

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 211239 · View the label on DailyMed

Revision date stated in the text: October 2024

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Bromfenac

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Nonsteroidal Anti-inflammatory Drug
Active ingredient Bromfenac sodium 0.75 mg/mL
Dosage form Solution/ drops
Route Ophthalmic
Marketing status listed in the FDA NDC Directory
Company (applicant) LUPIN
FDA approval ANDA 211239Abbreviated New Drug Application (ANDA) – generic drug Approved February 2, 2024
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics BromSite, Prolensa with the same TE code
Manufacturers 13 labelers list this drug on DailyMed
Recalls
  • May 7, 2025: Class II recall: Failed Impurities/Degradation Specifications
Packages (NDC)
Package
0.75 mg/mL – 5 ml in 1 bottle / 1 in 1 carton NDC 68180-434-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.