OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION- olopatadine hydrochloride ophthalmic solution/ drops

Olopatadine Hydrochloride Ophthalmic Solution by

Drug Labeling and Warnings

Olopatadine Hydrochloride Ophthalmic Solution by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Olopatadine (0.1%) (equivalent to olopatadine hydrochloride 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 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.

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 and /or Sodium hydroxide (to adjust pH), Sodium chloride and Water for Injection.

QUESTIONS?

Call 1-888-375-3784

SPL UNCLASSIFIED SECTION

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

Made in India

Rev. 08/20

R-145 Re-order No. 371044

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

PRINCIPAL DISPLAY PANEL

NDC: 0536-1308-40

NOW AVAILABLE without a prescription

Twice Daily Relief

Olopatadine HCl

Ophthalmic Solution, USP, 0.1%

Antihistamine and Redness Reliever

Works in Minutes

Relief from Allergens:

pet dander

pollen

grass

ragweed

Twice Daily

Sterile

5 mL

Compare to active ingredient in Pataday Twice Daily Relief*

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

For Ages 2 and Older

30 DAY SUPPLY

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION 
olopatadine hydrochloride ophthalmic solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1308
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM)	OLOPATADINE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1308-40	1 in 1 CARTON	01/05/2021	06/30/2026
1		5 mL in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209619	01/05/2021	06/30/2026

Labeler - Rugby Laboratories (079246066)