Olopatadine Hydrochloride Ophthalmic Solution Solution/ Drops
FDA Label NDC 79903-450

13 label sections · Submitted to the FDA by Walmart Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walmart Inc. for the product Olopatadine Hydrochloride Ophthalmic Solution (NDC 79903-450). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Olopatadine (0.7%)

(equivalent to olopatadine hydrochloride 0.776%)

Purpose

Antihistamine

Use

temporarily relieves itchy 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 right away(1-800-222-1222).

Directions

  • adults and children 2 years of age and older: 
    • put 1 drop in the affected eye(s) once daily
    • do not use more than 1 drop in each eye 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 2°-25°C (36°-77°F)

Inactive Ingredients

benzalkonium chloride 0.015%(preservative), boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropyl gamma- cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone, and purified water

Questions?

1-888-287-1915

Principal Display Panel

EXTRA STRENGTH

Olopatadine Hydrochloride

Ophthalmic Solution USP, 0.7%

Antihistamine

ONCE DAILY RELIEF

Eye Allergy Itch Relief

FULL 24 HOUR

Works in Minutes


STERILE
2.5 mL (0.085 fl oz)

TAMPER EVIDENT: Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing. 

30 DAY SUPPLY


For Ages 2 and Older

Carton Label

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EXTRA STRENGTH

Olopatadine Hydrochloride

Ophthalmic Solution USP, 0.7%

Antihistamine

ONCE DAILY RELIEF

Eye Allergy Itch Relief

FULL 24 HOUR

Works in Minutes


STERILE
2.5 mL (0.085 fl oz)

TAMPER EVIDENT: Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing. 

30 DAY SUPPLY


For Ages 2 and Older








Container Label:

Placeholder_image_container (Placeholder Image Container)

Placeholder_image_container (Placeholder Image Container)

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