Label: OLOPATADINE HYDROCHLORIDE solution

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

Drug Label Information

Updated September 3, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

    Active ingredient
    Olopatadine (0.1%).
    (equivalent to olopatadine hydrochloride, USP 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 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 (1-800-222-1222) 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/sodium hydroxide (adjust pH), sodium chloride and water for injection

  • Questions?

    ✆1-855-274-4122

    Distributed by:
    MEIJER DISTRIBUTION, INC.
    GRAND RAPIDS, MI 49544
    www.meijer.com

    Made in India

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container)

    meijer         NDC 79481-1000-1
    olopatadine
    hydrochloride     ophthalmic
    solution USP,     0.1%
    Antihistamine and Redness Reliever
    Eye Allergy Itch & Redness Relief
    STERILE            5 mL (0.17 FL OZ)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container Carton)

    meijer          NDC 79481-1000-1
                          *Compare to Pataday
                             Twice Daily
                             active ingredient
    ORIGINAL PRESCRIPTION
                                  STRENGTH
    olopatadine
    hydrochloride
    ophthalmic
    solution USP,     0.1%
    ANTIHISTAMINE AND
    REDNESS RELIEVER
    Eye Allergy Itch & Redness Relief
    Works in Minutes, Relief from Allergens:
    • Pet Dander • Pollen • Grass • Ragweed
    TWICE DAILY
    STERILE
    0.17 FL OZ (5 mL)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container Carton)

  • INGREDIENTS AND APPEARANCE
    OLOPATADINE HYDROCHLORIDE 
    olopatadine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-1000
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE HYDROCHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-1000-11 in 1 CARTON07/15/2020
    15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20481207/15/2020
    Labeler - Meijer (006959555)
    Registrant - Aurobindo Pharma Limited (650082092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eugia Pharma Specialities Limited650498244ANALYSIS(79481-1000) , MANUFACTURE(79481-1000)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!