Olopatadine Hydrochloride Ophthalmic Solution Twice Daily

OLOPATADINE HYDROCHLORIDE OPHTHALMIC OPHTHALMIC HUMAN OTC DRUG

Olopatadine Hydrochloride Ophthalmic Solution Twice Daily is an FDA drug label for the active ingredient OLOPATADINE HYDROCHLORIDE OPHTHALMIC manufactured by DOLGENCORP, LLC administered by OPHTHALMIC. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20210629.

Generic name
OLOPATADINE HYDROCHLORIDE OPHTHALMIC
Manufacturer
DOLGENCORP, LLC
Product type
HUMAN OTC DRUG
Route
OPHTHALMIC
Dosage form
N/A
NDC
55910-109
Application
ANDA209619
Label effective
20210629

About this product

Olopatadine Hydrochloride Ophthalmic Solution Twice Daily is an FDA-registered drug product whose active ingredient is OLOPATADINE HYDROCHLORIDE OPHTHALMIC. It is labelled by DOLGENCORP, LLC taken by ophthalmic and marketed as a human otc drug product. Identifiers on file: NDC 55910-109, application ANDA209619, label effective 20210629. 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.

What it is used for

Across FDA labelling, products containing OLOPATADINE HYDROCHLORIDE OPHTHALMIC are most often described in connection with: temporarily relieves, red 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.

Active ingredients

ACTIVE INGREDIENT Olopatadine (0.1%) (equivalent to olopatadine hydrochloride 0.111%)

Indications & Usage

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

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

Warnings

WARNINGS For external use only

More products with the same ingredient

OLOPATADINE HYDROCHLORIDE OPHTHALMIC

OLOPATADINE HYDROCHLORIDE

Golden State Medical Supply, Inc. View label

Olopatadine Hydrochloride Ophthalmic Solution

Gland Pharma Limited View label

Olopatadine Hydrochloride Ophthalmic Solution

Gland Pharma Limited View label

How products containing OLOPATADINE HYDROCHLORIDE OPHTHALMIC compare

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.

Dosage formProductsManufacturerProducts
— — Gland Pharma Limited 2
— — DOLGENCORP, LLC 1
— — Golden State Medical Supply, Inc. 1
— — — —
— — — —

Frequently asked questions

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

Who makes Olopatadine Hydrochloride Ophthalmic Solution Twice Daily?
DOLGENCORP, LLC is the labeler of record for Olopatadine Hydrochloride Ophthalmic Solution Twice Daily. 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 Twice Daily 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 Twice Daily 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 Twice Daily been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.