OLOPATADINE HYDROCHLORIDE

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Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Olopatadine (0.1%).
(equivalent to olopatadine hydrochloride, USP 0.111%)

Purpose

OTC - PURPOSE SECTION

Antihistamine and Redness Reliever

Uses

INDICATIONS & USAGE SECTION

temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• 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

OTC - WHEN USING SECTION

• 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:

OTC - STOP USE SECTION

• 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

• only for use in the eye
• store between 4° to 25°C (39° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

✆1-855-274-4122

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-6341

NDC: 50090-6341-0 5 mL in a BOTTLE, PLASTIC / 1 in a CARTON

OLOPATADINE HYDROCHLORIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

• OLOPATADINE HYDROCHLORIDE
• OLOPATADINE
• BENZALKONIUM CHLORIDE
• SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
• SODIUM CHLORIDE
• HYDROCHLORIC ACID
• SODIUM HYDROXIDE
• WATER

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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Observed Orange Book product history#

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Product history page 1 of 2 · 44 observed states.

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