OLOPATADINE HYDROCHLORIDE solution/ drops

Olopatadine hydrochloride by

Drug Labeling and Warnings

Olopatadine hydrochloride by is a Otc medication manufactured, distributed, or labeled by Apotex Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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 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: 60505-6221-0

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60505-6221
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, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60505-6221-0	1 in 1 CARTON	10/06/2022
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	ANDA078350	10/06/2022

Labeler - Apotex Corp. (845263701)