Label: OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION- olopatadine hydrochloride ophthalmic solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 27, 2026

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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

  • INGREDIENTS AND APPEARANCE
    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)
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