Label: PATADAY ONCE DAILY RELIEF- olopatadine hydrochloride solution

  • NDC Code(s): 0065-0816-01, 0065-0816-02, 0065-0816-04, 0065-0816-12
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 21, 2022

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  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Olopatadine (0.7%)
    (equivalent to olopatadine hydrochloride 0.776%)    		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
      • do not use more than 1 drop in each eye 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 0.015%, boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropylgamma- cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone, and purified water

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    EXTRA STRENGTH

    Pataday®

    ONCE DAILY RELIEF

    Olopatadine hydrochloride
    ophthalmic solution 0.7%
    Antihistamine

    Eye Allergy Itch Relief
    FULL 24 HOUR

    Works in Minutes
    Relief from Allergens:
       • Pet Dander
       • Pollen
       • Grass
       • Ragweed

    Alcon

    STERILE
    2.5 mL (0.085 FL OZ) 

    EXTRA STRENGTH

    Pataday®

    ONCE DAILY RELIEF  

    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. 

    30 DAY SUPPLY

    Eye Allergy Itch Relief 
    Works in Minutes 
    For Ages 2 and Older

    ________Fill Line________  

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

    ACTUAL SIZE 

    NDC: 0065-0816-04  
    300038456-0620

    LOT:                         EXP.:

    3187 

    carton

    EXTRA STRENGTH

    Pataday    ®
    ONCE DAILY RELIEF
    Olopatadine hydrochloride 
    ophthalmic solution 0.7% Antihistamine

    2.5 mL (0.085 FL OZ)
    STERILE

    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.
    6201 South Freeway
    Fort Worth, TX 76134

    LOT:          EXP.:

    300038442-0620

    label
  • INGREDIENTS AND APPEARANCE
    PATADAY ONCE DAILY RELIEF 
    olopatadine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-0816
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Olopatadine Hydrochloride (UNII: 2XG66W44KF) (Olopatadine - UNII:D27V6190PM) Olopatadine7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Boric Acid (UNII: R57ZHV85D4)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Hydroxypropyl .Gamma.-Cyclodextrin (UNII: P6BYU725IU)  
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    Mannitol (UNII: 3OWL53L36A)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Povidone, Unspecified (UNII: FZ989GH94E)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-0816-041 in 1 CARTON09/01/2020
    12.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0065-0816-012 in 1 CARTON01/04/2021
    22.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:0065-0816-021 in 1 CARTON01/04/2021
    30.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:0065-0816-123 in 1 CARTON01/24/2022
    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
    NDANDA20627609/01/2020
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-0816)
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