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  5. Label Information: Olopatadine Hydrochloride

FDA Label for Olopatadine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IFYOU EXPERIENCE:
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. PRINCIPAL DISPLAY PANEL

Olopatadine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Apotex Corp.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Olopatadine (0.2%) (equivalent to olopatadine hydrochloride 0.222%)

                                 


Purpose



Antihistamine


Uses



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 Ifyou 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 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°C to 25°C (36°F to 77°F)

Inactive Ingredients



benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium dihydrate, hydrochloric acid and/or sodium hydroxide (to adjust pH), povidone, sodium chloride and water for injection


Questions?



1-800-706-5575


Principal Display Panel



ONCE DAILY RELIEF

Olopatadine HCl Ophthalmic Solution, USP 0.2%

Antihistamine

Eye Allergy Itch Relief

NDC 60505-6222-2


* Please review the disclaimer below.