OLOPATADINE- olopatadine hydrochloride solution/ drops 
Golden State Medical Supply, Inc.

----------

OLOPATADINE- olopatadine hydrochloride solution/ drops.

Drug Facts

Active ingredient

Olopatadine (0.1%)

(equivalent to olopatadine hydrochloride 0.111%)

Purpose

Antihistamine and redness reliever

Use

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 the 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 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 at 4° to 25°C (39° to 77°F).

Inactive ingredients

benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid and/or sodium hydroxide (adjust pH), sodium chloride, and water for injection

Questions?

Call toll-Free 1-800-932-5676 weekdays, 7:00 AM - 5:30 PM CST

Principal Display Panel Text for Container Label:

NDC 51407-499-05

Olopatadine HCl Ophthalmic

Solution, USP 0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

STERILE 5 mL (0.17 FL OZ)

51407-499-05LB.jpg

Principal Display Panel Text for Carton Label:

NDC 51407-499-05

Prescription

Strength

Olopatadine

HCl Ophthalmic

Solution, USP

0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

Works in Minutes

Relief from Allergens:

• Pet Dander

• Pollen

• Grass

• Ragweed

TWICE DAILY

STERILE

5 mL (0.17 FL OZ)

51407-499-05CB - 10-27-2021.jpg

OLOPATADINE 
olopatadine hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51407-499
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, UNSPECIFIED FORM (UNII: GR686LBA74)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51407-499-051 in 1 CARTON09/09/202112/31/2023
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20453201/10/201712/31/2023
Labeler - Golden State Medical Supply, Inc. (603184490)
Establishment
NameAddressID/FEIBusiness Operations
Akorn117696840label(51407-499) , manufacture(51407-499) , pack(51407-499) , analysis(51407-499) , sterilize(51407-499)

Revised: 8/2023
Document Id: 02fa8d3f-1fc4-041c-e063-6394a90a95ac
Set id: cd115efc-8d68-3e01-e053-2a95a90af93c
Version: 6
Effective Time: 20230815
 
Golden State Medical Supply, Inc.