Label: OLOPATADINE HYDROCHLORIDE solution

  • NDC Code(s): 16571-882-05
  • Packager: Rising Pharma Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 5, 2025

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  • ACTIVE INGREDIENT(S)
    Olopatadine (0.1%) (equivalent to olopatadine hydrochloride USP, 0.111%)
  • PURPOSE
    Antihistamine and redness reliever
  • USE(S)
    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 ...
  • 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 ...
  • Other information
    ▪ only for use in the eye  - ▪ store between 4°C to 25°C (39°F to 77°F)
  • Inactive ingredients
    benzalkonium chloride 0.01%, dibasic sodium phosphate anhydrous, hydrochloric acid/sodium hydroxide (adjust pH), water for injection, and sodium chloride
  • Questions?
    Contact Rising Pharma Holdings, Inc. at 1-844-474-7464
  • PRINCIPAL DISPLAY PANEL
    Rising                                  NDC 16571-882-05 - Olopatadine Hydrochloride Ophthalmic Solution, USP 0.1% Antihistamine and Redness Reliever - NOW AVAILABLE without a prescription - TWICE ...
  • INGREDIENTS AND APPEARANCE
    Product Information