Opcon-a Solution/ Drops
FDA Label NDC 24208-431

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 24208-431). 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, purposes, 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

Naphazoline HCl (0.02675%)

Pheniramine maleate (0.315%)

Purposes

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.

Questions Or Comments?

[phone icon] call: 1-800-553-5340

Distributed by:
Bausch & Lomb Americas Inc.
Bridgewater, NJ 08807 USA

Package/Label Principal Display Panel

Carton (Carton)

Carton (Carton)

NDC 24208-431-15

BAUSCH + LOMB

Opcon-A ®
pheniramine maleate 0.315% and naphazoline
hydrochloride 0.02675% ophthalmic solution
ANTIHISTAMINE AND REDNESS RELIEVER

EYE DROPS
CLINICALLY PROVEN
EYE ALLERGY RELIEF

itching + redness

caused by pollen, ragweed,

grass, animal hair and dander

[teardrop icon]

STERILE 0.5 FL OZ (15 mL)

3844702
AB55211

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