OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION- olopatadine hydrochloride ophthalmic solution/ drops 
Rugby Laboratories

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ACTIVE INGREDIENT

Olopatadine (0.1%) (equivalent to olopatadine hydrochloride 0.111%)

PURPOSE

Antihistamine and redness reliever


USES

temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander

WARNINGS

For external use only

DO NOT USE

• if solution changes color or becomes cloudy 
• if you are sensitive to any ingredient in this product
• to treat contact lens related irritation

WHEN USING THIS PRODUCT

  • do not touch tip of container to any surface to avoid contamination
  • remove contact lenses before use
  • wait at least 10 minutes before reinserting contact lenses after use
  • do not wear a contact lens if your eye is red

STOP USE AND ASK DOCTOR IF

you experience:  

  • eye pain
  • changes in vision
  • increased redness of the eye
  • itching worsens or lasts for more than 72 hours

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• adults and children 2 years of age and older:
• put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice per day
• if using other ophthalmic products while using this product, wait at least 5 minutes between each product
• replace cap after each use  
• children under 2 years of age: consult a doctor

OTHER INFORMATION

• only for use in the eye  
• store between 4° to 25°C (39° to 77°F)

INACTIVE INGREDIENTS

Benzalkonium chloride 0.01%, Dibasic sodium phosphate, Hydrochloric acid and /or Sodium hydroxide (to adjust pH), Sodium chloride and Water for Injection.

QUESTIONS?

Call 1-888-375-3784

SPL UNCLASSIFIED SECTION

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

Made in India

Rev. 08/20

R-145 Re-order No. 371044

*This product is not manufactured or distributed by Alcon Laboratories Inc., distributor of Pataday® Twice Daily Relief . Pataday® is a registered trademark of Novartis AG.

PRINCIPAL DISPLAY PANEL

NDC 0536-1308-40

NOW AVAILABLE without a prescription

Twice Daily Relief

Olopatadine HCl

Ophthalmic Solution, USP, 0.1%

Antihistamine and Redness Reliever

Works in Minutes

Relief from Allergens:

• pet dander

• pollen

• grass

• ragweed

Twice Daily

Sterile

5 mL

Compare to active ingredient in Pataday Twice Daily Relief*

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

For Ages 2 and Older

30 DAY SUPPLY

Carton

OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION 
olopatadine hydrochloride ophthalmic solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1308
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1308-401 in 1 CARTON01/05/202106/30/2026
15 mL in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20961901/05/202106/30/2026
Labeler - Rugby Laboratories (079246066)

Revised: 3/2026
 
Rugby Laboratories