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Opcon-A Eye Drops: Package Insert / Prescribing Info

Package insert / product label
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 Aug 24, 2023.

Active ingredients

Naphazoline HCl (0.02675%)

Pheniramine maleate (0.315%)

Purposes

Redness reliever

Antihistamine

Indications and Usage for Opcon-A Eye Drops

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.

Opcon-A Eye Drops Dosage and Administration

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 Americas Inc.
Bridgewater, NJ 08807 USA

Package/Label Principal Display Panel

CARTON

TWIN PACK

NDC 24208-430-45

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]

STERILE
2 x 15 mL BOTTLES
(0.5 FL OZ EACH)

3844801
AB55299

OPCON-A
naphazoline hydrochloride and pheniramine maleate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24208-430
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.2675 mg in 1 mL
PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M) PHENIRAMINE MALEATE3.15 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24208-430-031 in 1 CARTON08/06/199404/01/2013
13 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:24208-430-151 in 1 CARTON08/06/1994
215 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3NDC:24208-430-301 in 1 CARTON08/06/199407/01/2011
330 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
4NDC:24208-430-452 in 1 CARTON07/01/2015
415 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02006506/08/1994
Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
NameAddressID/FEIBusiness Operations
Bausch & Lomb Incorporated114406598MANUFACTURE(24208-430)

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