OTC Medication Information: OLOPATADINE HYDROCHLORIDE

OLOPATADINE HYDROCHLORIDE — olopatadine hydrochloride solution
Wal-Mart Stores, Inc.

Drug Facts

Active ingredient
Olopatadine (0.1%).
(equivalent to olopatadine hydrochloride, USP 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 (1-800-222-1222) 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 between 4° to 25°C (39° to 77°F)

Inactive ingredients

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

Questions?

✆1-888-287-1915

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container)

NDC 79903-000-40
equateTM
Olopatadine Hydrochloride
Ophthalmic Solution USP, 0.1%
Antihistamine and Redness Reliever
EYE ALLERGY ITCH & REDNESS RELIEF
Sterile 5 mL (0.17 FL OZ)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container Carton)

NDC 79903-000-40
equateTM
Compare to Pataday® Twice Daily Relief active ingredient*
NOW AVAILABLE
WITHOUT A PRESCRIPTION
Olopatadine
Hydrochloride
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)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container Carton)
(click image for full-size original)

OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:79903-000
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLOPATADINE HYDROCHLORIDE (OLOPATADINE) OLOPATADINE HYDROCHLORIDE 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
SODIUM CHLORIDE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:79903-000-40 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 5 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (79903-000-40)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204812 07/15/2020
Labeler — Wal-Mart Stores, Inc. (051957769)

Revised: 06/2022 Wal-Mart Stores, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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