Label: PATADAY ONCE DAILY RELIEF- olopatadine hydrochloride solution

  • NDC Code(s): 0065-8150-01, 0065-8150-03, 0065-8150-04, 0065-8150-07
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 15, 2023

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  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Olopatadine 0.2%
    (equivalent to olopatadine hydrochloride 0.222%)    		Antihistamine
  • INDICATIONS & USAGE

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

  • WARNINGS

    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

    Stop use and ask a 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

    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) once daily, no more than once 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 2°-25°C (36°-77°F)
  • Inactive ingredients

    benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, purified water, and sodium chloride

  • Questions?

    In the U.S., call 1-800-757-9195 or email alcon.medinfo@alcon.com

  • PRINCIPAL DISPLAY PANEL

    Pataday®
    ONCE DAILY RELIEF
    Olopatadine hydrochloride 
    ophthalmic solution 0.2% Antihistamine

    2.5 mL (0.085 FL OZ)
    STERILE

    EYE ALLERGY ITCH RELIEF
    Only for use in the eye. Store between 2°– 25° C (36°– 77° F)

    TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase.

    Alcon Laboratories, Inc.
    Fort Worth, TX 76134

    LOT:          EXP.:

    H15725-219 

    label

    Original Prescription Strength

    Pataday

    ONCE DAILY RELIEF

    Olopatadine hydrochloride
    ophthalmic solution 0.2%
    Antihistamine

    Eye Allergy Itch Relief

    ONCE DAILY
    Works in Minutes Relief from Allergens:

    • Pet Dander
    • Pollen
    • Grass
    • Ragweed

    STERILE

    2.5 mL (0.085 FL OZ)

    Alcon

    Pataday

    ONCE DAILY RELIEF

    Eye Allergy Itch Relief
    Works in Minutes

    TAMPER EVIDENT: For your protection,
    this bottle has a seal imprinted with Alcon
    around the neck. Do not use if seal is
    damaged or missing at time of purchase.

    For Ages 2
    and Older
    30 DAY
    SUPPLY
    ________Fill Line________

    Alcon Laboratories, Inc.
    6201 South Freeway
    Fort Worth, Texas 76134
    Country of Origin: Japan

    ACTUAL SIZE

    NDC: 0065-6150-01       300037159-0520

    300037159-0520
  • INGREDIENTS AND APPEARANCE
    PATADAY ONCE DAILY RELIEF 
    olopatadine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-8150
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Olopatadine Hydrochloride (UNII: 2XG66W44KF) (Olopatadine - UNII:D27V6190PM) Olopatadine2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Povidone, Unspecified (UNII: FZ989GH94E)  
    Sodium Phosphate, Dibasic, Unspecified Form (UNII: GR686LBA74)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-8150-011 in 1 CARTON02/28/2020
    12.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0065-8150-032 in 1 CARTON02/28/2020
    22.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:0065-8150-041 in 1 CARTON02/28/2020
    30.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:0065-8150-073 in 1 CARTON01/15/2021
    42.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02154502/28/2020
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-8150)
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