Opcon-A Eye Drops

Generic Name: naphazoline hydrochloride and pheniramine maleate
Dosage Form: eye drops
Drug Facts

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

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)
• 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

Questions or Comments?

Call: 1-800-553-5340

Package/Label Principal Display Panel

Bausch & Lomb

Available without a prescription

Opcon-A®

PHENIRAMINE MALEATE 0.315%
AND NAPHAZOLINE HYDROCHLORIDE 0.02675%
OPHTHALMIC SOLUTION

ITCHING AND REDNESS RELIEVER EYE DROPS

Eye Allergy Relief

0.5 FL OZ (15 mL)

OPCON-A  naphazoline hydrochloride and pheniramine maleate  solution/ drops

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 24208-430 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE 0.2675 mg  in 1 mL PHENIRAMINE MALEATE (PHENIRAMINE) PHENIRAMINE MALEATE 3.15 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE   BORIC ACID   EDETATE DISODIUM   HYPROMELLOSE   WATER   SODIUM BORATE   SODIUM CHLORIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 24208-430-03 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 1 3 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-430-03) 2 24208-430-15 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 2 15 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-430-15) 3 24208-430-30 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 3 30 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-430-30)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020065	06/08/1994

Labeler - Bausch & Lomb Incorporated (196603781)

Establishment
Name	Address	ID/FEI	Operations
Bausch & Lomb Incorporated		114406598	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Loba Feinchemie AG		300137478	API MANUFACTURE

Revised: 07/2010Bausch & Lomb Incorporated