SPL v4
SPL
SPL Set ID d15e4288-c315-48dc-b120-6836a4b4b8c6
Route
OPHTHALMIC
Published
Effective Date 2022-06-16
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Olopatadine (2 mg)
Inactive Ingredients
Benzalkonium Chloride Sodium Phosphate, Dibasic, Unspecified Form Edetate Disodium Hydrochloric Acid Sodium Hydroxide Povidone, Unspecified Sodium Chloride Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2020-07-15

Description

Active ingredient Olopatadine (0.2%) (equivalent to olopatadine hydrochloride, USP 0.222%)

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Active ingredient Olopatadine (0.2%) (equivalent to olopatadine hydrochloride, USP 0.222%)

Use

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

Warnings

For external use only

Directions
  • adults and children 2 years of age and older:
    • put 1 drop in the affected eye(s) once daily, no more than once 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

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
Drug Facts

Active ingredient

Olopatadine (0.2%)

(equivalent to olopatadine hydrochloride, USP 0.222%)

Questions?

✆ 1-855-274-4122



Distributed by:

MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com



Made in India

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, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, sodium chloride and water for injection

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
Keep Out of Reach of Children.

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

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
Package Label Principal Display Panel 0.2% (2.5 Ml Container)

Meijer                      NDC 79481-1001-2                

olopatadine 

hydrochloride
ophthalm

solution USP, 0.2%

Antihistamine

Eye Allergy Itch Relief

STERILE                  2.5 mL (0.085 FL OZ)

Package Label Principal Display Panel 0.2% (2.5 Ml Container Carton)

meijer                                 NDC 79481-1001-2

                                           *Compare to Pataday

                                           Once Daily

                                            active ingredient

ORIGINAL PRESCRIPTION

STRENGTH

olopatadine

hydrochloride

ophthalmic

solution
USP, 0.2%

ANTIHISTAMINE

Eye Allergy Itch Relief

Works in Minutes, Relief from Allergens:

• Pet Dander • Pollen  • Grass • Ragweed

ONCE

DAILY

STERILE

0.085 FL OZ (2.5 mL)

Package Label Principal Display Panel 0.2% (2.5 Ml Container Carton) Twin Pack

Twin Pack

meijer                                          NDC 79481-1001-4

                                                     *Compare to Pataday

                                                     Once Daily

                                                     active ingredient

NOW AVAILABLE without

a prescription

olopatadine

hydrochloride

ophthalmic

solution
USP, 0.2%

Antihistamine

Eye Allergy Itch Relief

Works in Minutes Relief from Allergens:

• Pet Dander • Pollen • Grass • Ragweed

ONCE

DAILY

STERILE

Two 2.5 mL Bottles

(0.085 FL OZ EACH)


Structured Label Content

Use

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

Purpose

Antihistamine

Warnings

For external use only

Directions
  • adults and children 2 years of age and older:
    • put 1 drop in the affected eye(s) once daily, no more than once 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

Do Not Use (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
Drug Facts

Active ingredient

Olopatadine (0.2%)

(equivalent to olopatadine hydrochloride, USP 0.222%)

Questions?

✆ 1-855-274-4122



Distributed by:

MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com



Made in India

Other Information (Other information)
  • only for use in the eye
  • store between 4° to 25°C (39° to 77°F)
Inactive Ingredients (Inactive ingredients)

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

When Using This Product (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
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Stop Use and Ask A Doctor If You Experience: (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
Package Label Principal Display Panel 0.2% (2.5 Ml Container) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container))

Meijer                      NDC 79481-1001-2                

olopatadine 

hydrochloride
ophthalm

solution USP, 0.2%

Antihistamine

Eye Allergy Itch Relief

STERILE                  2.5 mL (0.085 FL OZ)

Package Label Principal Display Panel 0.2% (2.5 Ml Container Carton) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton))

meijer                                 NDC 79481-1001-2

                                           *Compare to Pataday

                                           Once Daily

                                            active ingredient

ORIGINAL PRESCRIPTION

STRENGTH

olopatadine

hydrochloride

ophthalmic

solution
USP, 0.2%

ANTIHISTAMINE

Eye Allergy Itch Relief

Works in Minutes, Relief from Allergens:

• Pet Dander • Pollen  • Grass • Ragweed

ONCE

DAILY

STERILE

0.085 FL OZ (2.5 mL)

Package Label Principal Display Panel 0.2% (2.5 Ml Container Carton) Twin Pack (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton) Twin Pack)

Twin Pack

meijer                                          NDC 79481-1001-4

                                                     *Compare to Pataday

                                                     Once Daily

                                                     active ingredient

NOW AVAILABLE without

a prescription

olopatadine

hydrochloride

ophthalmic

solution
USP, 0.2%

Antihistamine

Eye Allergy Itch Relief

Works in Minutes Relief from Allergens:

• Pet Dander • Pollen • Grass • Ragweed

ONCE

DAILY

STERILE

Two 2.5 mL Bottles

(0.085 FL OZ EACH)


Advanced Ingredient Data


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