SPL v4
SPL
SPL Set ID 5d79fc06-a25f-debb-f08b-523ff26df900
Route
OPHTHALMIC
Published
Effective Date 2026-01-15
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Olopatadine (7 mg)
Inactive Ingredients
Benzalkonium Chloride Boric Acid Hydrochloric Acid Hydroxypropyl .gamma.-cyclodextrin Hypromellose 2910 (4000 Mpa.s) Mannitol Polyethylene Glycol 400 Povidone K30 Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2026-01-15

Description

Olopatadine (0.7%) (equivalent to olopatadine hydrochloride 0.776%)

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine



Description

Olopatadine (0.7%) (equivalent to olopatadine hydrochloride 0.776%)

Use

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

Section 42229-5

Distributed by:

CARDINAL HEALTH,

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Made in India

©2025 Cardinal Health. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

100% Money Back Guarantee

Return to place of purchase if not satisfied.

CIN 6051569

Rev . 01/26

*This product is not manufactured or distributed by Alcon Laboratories Inc., distributor of Pataday® Once Daily Relief Extra Strength. Pataday® is a registered trademark of Novartis AG.

Warnings

For external use only

Directions
  • adults and children 2 years of age and older:
  • put 1 drop in the affected eye(s) once daily
  • do not use more than 1 drop in each eye 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
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

Questions?

call toll-free weekdays 8 AM to 8 PM EST at 1-888-375-3784

Active Ingredient

Olopatadine (0.7%) (equivalent to olopatadine hydrochloride 0.776%)

Other Information

• only for use in the eye

• store between 2° to 25°C (36° to 77°F)

Inactive Ingredients

benzalkonium chloride 0.015% (preservative), boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropyl gamma-cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone and purified water.

Principal Display Panel

Carton Label:

NDC 70000-0746-1



Extra Strength

Eye Allergy Itch Relief

Olopatadine Hydrochloride

Ophthalmic Solution USP, 0.7%

Antihistamine

ONCE DAILY RELIEF

Full 24HR

Works in Minutes

Sterile

2.5 mL (0.085 fl oz)

 

Compare to Pataday Once Daily Relief Extra Strength active ingredient*

TAMPER EVIDENT: Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

For Ages 2 and Older

30 DAY SUPPLY







Bottle Label:



Extra Strength

Eye Allergy Itch Relief

Olopatadine Hydrochloride

Ophthalmic Solution USP, 0.7%

Antihistamine

ONCE DAILY RELIEF

Sterile 

2.5 mL (0.085 fl oz)



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 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 right away(1-800-222-1222).


Structured Label Content

Use (USE)

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

Section 42229-5 (42229-5)

Distributed by:

CARDINAL HEALTH,

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Made in India

©2025 Cardinal Health. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

100% Money Back Guarantee

Return to place of purchase if not satisfied.

CIN 6051569

Rev . 01/26

*This product is not manufactured or distributed by Alcon Laboratories Inc., distributor of Pataday® Once Daily Relief Extra Strength. Pataday® is a registered trademark of Novartis AG.

Purpose (PURPOSE)

Antihistamine



Warnings (WARNINGS)

For external use only

Directions (DIRECTIONS)
  • adults and children 2 years of age and older:
  • put 1 drop in the affected eye(s) once daily
  • do not use more than 1 drop in each eye 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
Do Not Use (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

Questions? (QUESTIONS?)

call toll-free weekdays 8 AM to 8 PM EST at 1-888-375-3784

Active Ingredient (ACTIVE INGREDIENT)

Olopatadine (0.7%) (equivalent to olopatadine hydrochloride 0.776%)

Other Information (OTHER INFORMATION)

• only for use in the eye

• store between 2° to 25°C (36° to 77°F)

Inactive Ingredients (INACTIVE INGREDIENTS)

benzalkonium chloride 0.015% (preservative), boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropyl gamma-cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone and purified water.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Carton Label:

NDC 70000-0746-1



Extra Strength

Eye Allergy Itch Relief

Olopatadine Hydrochloride

Ophthalmic Solution USP, 0.7%

Antihistamine

ONCE DAILY RELIEF

Full 24HR

Works in Minutes

Sterile

2.5 mL (0.085 fl oz)

 

Compare to Pataday Once Daily Relief Extra Strength active ingredient*

TAMPER EVIDENT: Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

For Ages 2 and Older

30 DAY SUPPLY







Bottle Label:



Extra Strength

Eye Allergy Itch Relief

Olopatadine Hydrochloride

Ophthalmic Solution USP, 0.7%

Antihistamine

ONCE DAILY RELIEF

Sterile 

2.5 mL (0.085 fl oz)



When Using This Product (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 Doctor If (STOP USE AND ASK 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 (KEEP OUT OF REACH OF CHILDREN)

If swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222).


Advanced Ingredient Data


Raw Label Data

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