OLOPATADINE- olopatadine hydrochloride solution/ drops. Drug Facts

Olopatadine by

Drug Labeling and Warnings

Olopatadine by is a Otc medication manufactured, distributed, or labeled by Golden State Medical Supply, Inc., Akorn. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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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)

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)

OLOPATADINE 
olopatadine hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51407-499
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, UNSPECIFIED FORM (UNII: GR686LBA74)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51407-499-05	1 in 1 CARTON	09/09/2021	12/31/2023
1		5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204532	01/10/2017	12/31/2023

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

Establishment
Name	Address	ID/FEI	Business Operations
Akorn		117696840	label(51407-499) , manufacture(51407-499) , pack(51407-499) , analysis(51407-499) , sterilize(51407-499)

Revised: 8/2023

Document Id: 02fa8d3f-1fc4-041c-e063-6394a90a95ac

34390-5

Set id: cd115efc-8d68-3e01-e053-2a95a90af93c

Version: 6

Effective Time: 20230815