Olopatadine Hydrochloride Ophthalmic Solution

Olopatadine Hydrochloride Ophthalmic Solution is an FDA-registered drug product whose active ingredient is OLOPATADINE HYDROCHLORIDE OPHTHALMIC. It is labelled by Gland Pharma Limited taken by ophthalmic and marketed as a human otc drug product. Identifiers on file: NDC 68083-231, application ANDA209752, label effective 20260422. It is one of 4 FDA drug label records sharing the active ingredient OLOPATADINE HYDROCHLORIDE OPHTHALMIC. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing OLOPATADINE HYDROCHLORIDE OPHTHALMIC are most often described in connection with: temporarily relieves, itchy eyes, due pollen, ragweed grass, animal hair. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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

WARNINGS For external use only

FDA lists 4 drug label records with OLOPATADINE HYDROCHLORIDE OPHTHALMIC as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

3 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Olopatadine Hydrochloride Ophthalmic Solution used for?
USE temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander

Who makes Olopatadine Hydrochloride Ophthalmic Solution?
Gland Pharma Limited is the labeler of record for Olopatadine Hydrochloride Ophthalmic Solution. 4 FDA label records share the active ingredient OLOPATADINE HYDROCHLORIDE OPHTHALMIC, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Olopatadine Hydrochloride Ophthalmic Solution come in?
administered by ophthalmic. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Olopatadine Hydrochloride Ophthalmic Solution prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing OLOPATADINE HYDROCHLORIDE OPHTHALMIC?
Yes. 4 FDA drug label records list OLOPATADINE HYDROCHLORIDE OPHTHALMIC as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Olopatadine Hydrochloride Ophthalmic Solution been recalled?
3 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.