BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION REDNESS RELIEVER EYE DROPS

Manufacturer
Rugby Laboratories
Effective date
2024-07-15
Label type
Human OTC Drug Label
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:59:08

Label at a glance#

ProductBRIMONIDINE TARTRATE
Active ingredientBRIMONIDINE TARTRATE
Label structure14 sections

Dosage and administration

adults and children 5 years of age and over: instill 1 drop in the affected eye(s) every 6-8 hours do not use more than 4 times daily remove contact lenses before use wait at least 10 minutes before re-inserting contact lenses after use if using other ophthalmic products while using this product, wait at least 5 minutes between each product to avoid contamination, do not touch tip of container to any surface repla...

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Brimonidine tartrate (0.025%)

PURPOSE

OTC - PURPOSE SECTION

Redness reliever

USE(S)

INDICATIONS & USAGE SECTION

• relieves redness of the eye due to minor eye irritations

WARNINGS

WARNINGS SECTION

For external use only

DO NOT USE

OTC - DO NOT USE SECTION

• if solution changes color or becomes cloudy

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION

  • you experience eye pain, changes in vision, continued redness or irritation of the eye
  • condition worsens or persists for more than 3 days

PREGNANCY/BREASTFEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • adults and children 5 years of age and over:
  • instill 1 drop in the affected eye(s) every 6-8 hours
  • do not use more than 4 times daily
  • remove contact lenses before use
  • wait at least 10 minutes before re-inserting contact lenses after use
  • if using other ophthalmic products while using this product, wait at least 5 minutes between each product
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after each use
  • children under 5 years of age: consult a doctor

OTHER INFORMATION

OTHER SAFETY INFORMATION

• store at 15° to 25°C (59° to 77°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, calcium chloride dihydrate, glycerin, potassium chloride, sodium borate decahydrate, sodium chloride, water for injection. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call: 1-888-375-3784

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

(800) 616-2471

Made in India

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


BRIMONIDINE TARTRATE 
OPHTHALMIC SOLUTION 0.025% 
REDNESS RELIEVER EYE DROPS 


•Works in 1 minute 
•Lasts up to 8 hours 


Sterile 
0.08 FL OZ (2.5 mL) 

CartonCarton

  

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1432BRIMONIDINE TARTRATE SOLUTION/ DROPS [RUGBY LABORATORIES]2Unmatched20240715_bd54bc71-675a-a4f6-a295-c9e2864c9f2b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-14320536-1432-23, 0536-1432-67

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
622d8535-a050-cdf0-268e-8167b895c8d6bd54bc71-675a-a4f6-a295-c9e2864c9f2b2025-08-13WarningsExact identifier
spl set id: bd54bc71-675a-a4f6-a295-c9e2864c9f2b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.