Label: OLOPATADINE HYDROCHLORIDE solution/ drops

  • NDC Code(s): 51407-663-05
  • Packager: Golden State Medical Supply, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 28, 2023

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  • Active ingredient(in each tablet)

    Olopatadine (01.%) (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 a doctor ifyou 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 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 4ºC to 25ºC (39ºF to 77ºF)
  • Inactive ingredients

    benzalkonium chloride 0.01%, dibasic sodium phosphate (anhydrous), hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water and sodium chloride

  • Questions?

    1-800-706-5575

  • Principal Display Panel

    TWICE DAILY RELIEF

    Olopatadine HCl Ophthalmic Solution, USP 0.1%

    Antihistamine and Redness Reliever

    Eye Allergy Itch & Redness Relief

    NDC 51407-663-05

    51407-663-05 container.jpg

    51407-663-05.jpg

  • INGREDIENTS AND APPEARANCE
    OLOPATADINE HYDROCHLORIDE 
    olopatadine hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51407-663
    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, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51407-663-051 in 1 CARTON10/03/2022
    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
    ANDAANDA07835012/07/2015
    Labeler - Golden State Medical Supply, Inc. (603184490)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotex Inc.209429182analysis(51407-663) , manufacture(51407-663)
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