FDA Label for Pataday Once Daily Relief

View Indications, Usage & Precautions

Pataday Once Daily Relief Product Label

The following document was submitted to the FDA by the labeler of this product Alcon Laboratories, Inc.. 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.

Otc - Purpose



Active IngredientsPurpose
Olopatadine 0.2%
(equivalent to olopatadine hydrochloride 0.222%)
Antihistamine

Indications & Usage



Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander


Warnings



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

Otc - Stop Use



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

Otc - Keep Out Of Reach Of Children



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) 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°-25°C (36°-77°F)

Inactive Ingredients



benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, purified water, and sodium chloride


Questions?



In the U.S., call 1-800-757-9195 or email [email protected]


Principal Display Panel



NOW AVAILABLE
without a prescription

Pataday®
ONCE DAILY RELIEF
Olopatadine hydrochloride
ophthalmic solution 0.2%
Antihistamine

Eye Allergy Itch Relief

ONCE DAILY

Works in Minutes
Relief from Allergens:
   • Pet Dander
   • Pollen
    • Grass
   • Ragweed

STERILE
2.5 mL (0.085 FL OZ) 

Alcon  

Pataday®

ONCE DAILY RELIEF  

Eye Allergy Itch Relief
Works in Minutes

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase. 

For Ages 2 and Older
30 DAY SUPPLY 

________Fill Line________  

6201 South Freeway
Fort Worth, Texas 76134
Country of Origin: Japan

ACTUAL SIZE 

NDC: 0065-8150-01  
9017921-1219 

Pataday®
ONCE DAILY RELIEF
Olopatadine hydrochloride 
ophthalmic solution 0.2% Antihistamine

2.5 mL (0.085 FL OZ)
STERILE

EYE ALLERGY ITCH RELIEF
Only for use in the eye. Store between 2°– 25° C (36°– 77° F)

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase.

Alcon Laboratories, Inc.
Fort Worth, TX 76134

LOT:          EXP.:

H15725-219 


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