Pataday Once Daily Relief Solution
FDA Label NDC 0065-8150

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alcon Laboratories, Inc. for the product Pataday Once Daily Relief (NDC 0065-8150). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, indications & usage, warnings, do not use, when using this product, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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 

Carton (Carton)

Carton (Carton)

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 

Label (Label)

Label (Label)

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