Label: OLOPATADINE HYDROCHLORIDE solution

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

Drug Label Information

Updated August 11, 2022

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

View All Sections
  • Drug Facts

    Active ingredient
    Olopatadine (0.2%)
    (equivalent to olopatadine hydrochloride, USP 0.222%)

  • Purpose

    Antihistamine

  • Use

    temporarily relieves itchy 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) 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 4° to 25°C (39° to 77°F)
  • Inactive ingredients

    benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, 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-0.2% (2.5 mL Container)

    Meijer                      NDC 79481-1001-2                
    olopatadine 
    hydrochloride     ophthalm
    solution USP, 0.2%
    Antihistamine
    Eye Allergy Itch Relief
    STERILE                  2.5 mL (0.085 FL OZ)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton)

    meijer                                 NDC 79481-1001-2
                                               *Compare to Pataday
                                               Once Daily
                                                active ingredient
    ORIGINAL PRESCRIPTION
    STRENGTH
    olopatadine
    hydrochloride
    ophthalmic
    solution     USP, 0.2%
    ANTIHISTAMINE
    Eye Allergy Itch Relief
    Works in Minutes, Relief from Allergens:
    • Pet Dander • Pollen  • Grass • Ragweed
    ONCE
    DAILY
    STERILE
    0.085 FL OZ (2.5 mL)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton) Twin Pack

    Twin Pack
    meijer                                          NDC 79481-1001-4
                                                         *Compare to Pataday
                                                         Once Daily
                                                         active ingredient
    NOW AVAILABLE without
    a prescription
    olopatadine
    hydrochloride
    ophthalmic
    solution     USP, 0.2%
    Antihistamine
    Eye Allergy Itch Relief
    Works in Minutes Relief from Allergens:
    • Pet Dander • Pollen • Grass • Ragweed
    ONCE
    DAILY
    STERILE
    Two 2.5 mL Bottles
    (0.085 FL OZ EACH)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton) Twin Pack

  • INGREDIENTS AND APPEARANCE
    OLOPATADINE HYDROCHLORIDE 
    olopatadine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-1001
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE HYDROCHLORIDE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-1001-21 in 1 CARTON07/15/2020
    12.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:79481-1001-42 in 1 CARTON07/15/2020
    22.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20999507/15/2020
    Labeler - Meijer (006959555)
    Registrant - Aurobindo Pharma Limited (650082092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eugia Pharma Specialities Limited650498244ANALYSIS(79481-1001) , MANUFACTURE(79481-1001)
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!