Olopatadine Solution/ Drops
FDA Label NDC 50090-7959

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Olopatadine (NDC 50090-7959). 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 otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Drug Facts

Active Ingredients
Purpose
Olopatadine (0.1%)
(equivalent to olopatadine
hydrochloride 0.111%)
Antihistamine and Redness Reliever

Indications & Usage

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

Warnings

Warnings

For external use only

Otc - 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

    • 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

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

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

Storage And Handling

Other information

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

Inactive Ingredient

Inactive ingredients

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

Otc - Questions

Questions?

Customer Care # 1-800-417-9175

Other

Manufactured for:

Somerset Therapeutics, LLC

Somerset, NJ 08873

Made in India

Code No.:KR/DRUGS/KTK/28/289/97

ST-OLP11-OTC/P/01

1200809

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