BromSite (Bromfenac sodium): Uses, Side Effects and Dosage

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

INSTRUCTIONS FOR USE

BromSite®[BRŏM- sahyt]

(bromfenac ophthalmic solution) 0.075%

Read this Instructions for Use before you start using BromSite 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 BromSite:

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

Before you use BromSite for the first time:

Tear open the foil pouch using the perforated notch and remove the BromSite bottle. Throw away the foil pouch.
Remove the white cap by turning it in the clockwise direction ( See FIGURE A). Throw away the white cap.

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.

Follow Steps 1 to 5 each time you use BromSite.

Step 1.Wash your hands well.

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

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

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

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

How do I store BromSite?

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

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

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

US Patent No. 8,778,999

BromSite and DuraSite are registered trademarks of Sun Pharmaceutical Industries Limited

Rev.: 03/2023

VISX001650R01

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 206911 · View the label on DailyMed

Revision date stated in the text: March 2023

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

Drug information for BromSite

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 0.76 mg/mL

Dosage form

Solution/ drops

Route

Ophthalmic

Marketing status

listed in the FDA NDC Directory

Company (applicant)

SUN PHARM

FDA approval

NDA 206911New Drug Application (NDA) Approved April 8, 2016

Reference listed drug

This is the reference listed drug (RLD) that generics are compared with.

Therapeutic equivalence (TE) code

ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).

Generics

Bromfenac, Prolensa with the same TE code

Manufacturers

1 labelers list this drug on DailyMed

Packages (NDC)

Package
0.76 mg/mL – 5 ml in 1 bottle, dropper / 1 in 1 pouch / 1 in 1 carton NDC 49708-754-41

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.