SPL v3
SPL
SPL Set ID edb068e2-1835-483e-e59c-bcbe13b66d76
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:

RUGBY® LABORATORIES

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

Made in India

Rev. 09/25 R-145 Re-order No. 371269

*This product is not manufactured or distributed by Alcon Laboratories Inc., distributor of Extra Strength Pataday® Once Daily Relief . 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 0536-1478-23

extra strength

olopatadine HCl

ophthalmic solution USP, 0.7%

antihistamine

once daily relief

eye allergy itch relief

works in minutes

FULL 24 HR

relief from allergens:

• pet dander

• pollen

• grass

• ragweed

2.5 mL (0.085 fl oz)

sterile 

Compare to active ingredient in Extra Strength Pataday Once Daily Relief*

Tamper Evident: Do not use if seal is damaged or missing at time of purchase.

For Ages 2 and Older

30 DAY SUPPLY







Bottle Label:



extra strength

olopatadine HCl

ophthalmic solution USP, 0.7%

antihistamine

once daily relief

eye allergy itch relief

2.5 mL (0.085 fl oz)

sterile 



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:

RUGBY® LABORATORIES

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

Made in India

Rev. 09/25 R-145 Re-order No. 371269

*This product is not manufactured or distributed by Alcon Laboratories Inc., distributor of Extra Strength Pataday® Once Daily Relief . 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 0536-1478-23

extra strength

olopatadine HCl

ophthalmic solution USP, 0.7%

antihistamine

once daily relief

eye allergy itch relief

works in minutes

FULL 24 HR

relief from allergens:

• pet dander

• pollen

• grass

• ragweed

2.5 mL (0.085 fl oz)

sterile 

Compare to active ingredient in Extra Strength Pataday Once Daily Relief*

Tamper Evident: Do not use if seal is damaged or missing at time of purchase.

For Ages 2 and Older

30 DAY SUPPLY







Bottle Label:



extra strength

olopatadine HCl

ophthalmic solution USP, 0.7%

antihistamine

once daily relief

eye allergy itch relief

2.5 mL (0.085 fl oz)

sterile 



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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