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%)

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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 Item Code (Source) NDC: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  
Packaging
# Item Code Package Description
1 NDC:24208-430-03 1 BOTTLE, DROPPER (BOTTLE) in 1 CARTON
1 3 mL in 1 BOTTLE, DROPPER
2 NDC:24208-430-15 1 BOTTLE, DROPPER (BOTTLE) in 1 CARTON
2 15 mL in 1 BOTTLE, DROPPER
3 NDC:24208-430-30 1 BOTTLE, DROPPER (BOTTLE) in 1 CARTON
3 30 mL in 1 BOTTLE, DROPPER
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: 07/2010
 
Bausch & Lomb Incorporated



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