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Home > Drugs > Ophthalmic antihistamines and decongestants > Opcon-a > Opcon-A Eye Drops Prescribing Information
Ophthalmic antihistamines and decongestants
https://themeditary.com/pro/opcon-a-eye-drops-prescribing-information-13990.html

Opcon-A Eye Drops Prescribing Information

Drug Detail:Opcon-a (Naphazoline and pheniramine ophthalmic [ naf-az-oh-leen-and-fen-ir-a-meen-off-thal-mik ])

Drug Class: Ophthalmic antihistamines and decongestants

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

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.

Related/similar drugs

triprolidine, fluorometholone ophthalmic, FML, Naphcon-A, Flarex, Visine-A

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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