FDA Label for Olopatadine Hydrochloride

View Indications, Usage & Precautions

Olopatadine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Rite Aid Corporation. 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.

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:
RITE AID
200 NEWBERRY COMMONS
ETTERS, PA 17319
www.riteaid.com
MADE IN INDIA


Package Label-Principal Display Panel-0.1% (5 Ml Container)



                                                         NDC 11822-0064-1
EYE ALLERGY ITCH                              TWICE DAILY
& REDNESS RELIEF
OLOPATADINE HYDROCHLORIDE
OPHTHALMIC SOLUTION
USP, 0.1%
Antihistamine &
Redness Reliever                  5 mL
STERILE                 (0.17 FL OZ)


Package Label-Principal Display Panel-0.1% (5 Ml Container Carton)



Compare to the active ingredient
in Pataday® Twice Daily Relief*                               
                                                     NDC 11822-0064-1
TWICE DAILY RELIEF

EYE ALLERGY
ITCH &
REDNESS RELIEF

OLOPATADINE
HYDROCHLORIDE
OPHTHALMIC
SOLUTION USP, 0.1%
Antihistamine &
Redness Reliever
Works in Minutes                            
Relief from Allergens:                        
• Pet Dander • Pollen
• Grass • Ragweed
                                               STERILE
TWICE DAILY
Now available
without a
prescription                                     5 mL
                                           (0.17 FL OZ)



* Please review the disclaimer below.