Active ingredient(in each tablet)

Olopatadine (01.%) (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 a doctor ifyou 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 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 4ºC to 25ºC (39ºF to 77ºF)

Inactive ingredients

benzalkonium chloride 0.01%, dibasic sodium phosphate (anhydrous), hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water and sodium chloride

Questions?

1-800-706-5575

Principal Display Panel

TWICE DAILY RELIEF

Olopatadine HCl Ophthalmic Solution, USP 0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

NDC 51407-663-05

51407-663-05 container.jpg

OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51407-663
Route of Administration	OPHTHALMIC

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

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51407-663-05	1 in 1 CARTON	10/03/2022
1		5 mL in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078350	12/07/2015

Labeler - Golden State Medical Supply, Inc. (603184490)

Name	Address	ID/FEI	Business Operations
Establishment
Apotex Inc.		209429182	analysis(51407-663) , manufacture(51407-663)

OLOPATADINE HYDROCHLORIDE. Drug Facts