OLOPATADINE HYDROCHLORIDE- olopatadine hydrochloride solution/ drops 
Apotex Corp.

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Drug Facts

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

Consult a doctor

Other information

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

Bottle Label

Carton Label

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60505-6221
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (Olopatadine - UNII:D27V6190PM) Olopatadine1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60505-6221-01 in 1 CARTON10/06/2022
15 mL in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07835010/06/2022
Labeler - Apotex Corp. (845263701)

Revised: 12/2023
Document Id: a9c3f5e2-ee04-a6e7-313c-ec1f4c890060
Set id: cc178825-1a4e-6bca-a00d-aa28d5abe589
Version: 2
Effective Time: 20231204
 
Apotex Corp.