Olopatadine Hydrochloride Solution
FDA Label NDC 46122-823

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisourcebergen Drug Corp for the product Olopatadine Hydrochloride (NDC 46122-823). 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, do not use, when using this product, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Do Not Use

→ When Using This Product

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Otc - Purpose

Active Ingredient	Purpose
Olopatadine (0.1%). (equivalent to olopatadine hydrochloride 0.111%)	Antihistamine and redness reliever

Indications & Usage

Uses

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

Warnings

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

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.

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

Other Information

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

Inactive Ingredients

benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid and/ or sodium hydroxide (to adjust PH), sodium chloride and water for injection.