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Opcon-A Eye Drops

Package insert / prescribing information
Generic name: naphazoline hydrochloride and pheniramine maleate
Dosage form: eye drops
Drug class: Ophthalmic antihistamines and decongestants

Medically reviewed by Drugs.com. Last updated on Feb 21, 2022.

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)

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
WATER
SODIUM BORATE
SODIUM CHLORIDE
HYDROCHLORIC ACID
HYPROMELLOSE, UNSPECIFIED
Packaging
# Item Code Package Description
1 NDC:24208-430-03 1 BOTTLE, DROPPER in 1 CARTON
1 3 mL in 1 BOTTLE, DROPPER
2 NDC:24208-430-15 1 BOTTLE, DROPPER in 1 CARTON
2 15 mL in 1 BOTTLE, DROPPER
3 NDC:24208-430-30 1 BOTTLE, DROPPER in 1 CARTON
3 30 mL in 1 BOTTLE, DROPPER
4 NDC:24208-430-45 2 BOTTLE, DROPPER in 1 CARTON
4 15 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(24208-430)
Bausch & Lomb Incorporated

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