OPCON-A- naphazoline hydrochloride and pheniramine maleate solution/ drops

Opcon-A by

Drug Labeling and Warnings

Opcon-A by is a Otc medication manufactured, distributed, or labeled by Bausch & Lomb Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.2675 mg  in 1 mL
PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M)	PHENIRAMINE MALEATE	3.15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROCHLORIC ACID (UNII: QTT17582CB)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24208-430-03	1 in 1 CARTON	08/06/1994
1		3 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 24208-430-15	1 in 1 CARTON	08/06/1994
2		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC: 24208-430-30	1 in 1 CARTON	08/06/1994
3		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
4	NDC: 24208-430-45	2 in 1 CARTON	07/01/2015
4		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

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	Business Operations
Bausch & Lomb Incorporated		114406598	MANUFACTURE(24208-430)