FDA Label for Opcon-a
View Indications, Usage & Precautions
Opcon-a Product Label
The following document was submitted to the FDA by the labeler of this product Bausch & Lomb Incorporated. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
Questions Or Comments?
[phone icon] Call: 1-800-553-5340
Distributed by:
Bausch + Lomb, a division
of Bausch Health US LLC
Bridgewater, NJ 08807 USA
3844800
AB5529
Package/Label Principal Display Panel
TWIN PACK
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]
2 x 15 mL BOTTLES
STERILE (0.5 FL OZ EACH)
* Please review the disclaimer below.