Opcon-a Solution/ Drops
FDA Label NDC 24208-430

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bausch & Lomb Incorporated for the product Opcon-a (NDC 24208-430). 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 ingredients, purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if you experience, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ When Using This Product

→ Stop Use And Ask A Doctor If You Experience

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Package/label Principal Display Panel

Active Ingredients

Naphazoline HCl (0.02675%)

Pheniramine maleate (0.315%)

Purpose

Redness reliever

Antihistamine

Uses

temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander.

Warnings

For external use only

Do Not Use

if you are sensitive to any ingredient in this product
if solution changes color or becomes cloudy

Ask A Doctor Before Use If You Have

heart disease
high blood pressure
trouble urinating due to an enlarged prostate gland
narrow angle glaucoma

When Using This Product

overuse may cause more eye redness
pupils may become enlarged temporarily
do not touch tip of container to any surface to avoid contamination
you may feel a brief tingling after putting drops in eye
replace cap after use
remove contact lenses before using

Stop Use And Ask A Doctor If You Experience

eye pain
changes in vision
redness or irritation of the eye that worsens or lasts more than 72 hours

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away. Accidental oral ingestion in infants and children may lead to coma and marked reduction in body temperature.

Directions

Adults and children 6 years of age and older: Instill 1 or 2 drops in the affected eye(s) up to 4 times daily.
Children under 6 years: ask a doctor

Other Information

store at 20°-25°C (68°-77°F)
this package is child-resistant
protect from light
use before expiration date marked on the carton or bottle

Inactive Ingredients

benzalkonium chloride, boric acid, edetate disodium, hypromellose, purified water, sodium borate, sodium chloride. Hydrochloric acid may be used to adjust pH.