drug facts

Composition & Product

Active Ingredients

naphazoline (0.2675 mg) pheniramine (3.15 mg)

Inactive Ingredients

benzalkonium chloride boric acid edetate disodium water sodium borate sodium chloride hydrochloric acid hypromellose, unspecified

Identifiers & Packaging

Marketing Status

nda completed Since 1994-06-08 Until 2011-07-01

Medication Information

Warnings

For external use only

Uses

•
temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander

Purpose

Redness reliever Antihistamine

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.

Description

Naphazoline HCl (0.02675%) Pheniramine maleate (0.315%)

Purposes

Redness reliever

Antihistamine

Do Not Use

•
if you are sensitive to any ingredient in this product
•
if solution changes color or becomes cloudy

Active Ingredients

Naphazoline HCl (0.02675%)

Pheniramine maleate (0.315%)

Questions Or Comments?

[phone icon] call: 1-800-553-5340

Distributed by:

Bausch & Lomb Americas Inc.

Bridgewater, NJ 08807 USA

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

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.

Ask A Doctor Before Use If You Have

•
heart disease
•
high blood pressure
•
trouble urinating due to an enlarged prostate gland
•
narrow angle glaucoma

Package/label Principal Display Panel

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

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

Structured Label Content

Warnings

For external use only

Uses

•
temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander

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 (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 (Inactive ingredients)

benzalkonium chloride, boric acid, edetate disodium, hypromellose, purified water, sodium borate, sodium chloride. Hydrochloric acid may be used to adjust pH.

Purposes

Redness reliever

Antihistamine

Do Not Use (Do not use)

•
if you are sensitive to any ingredient in this product
•
if solution changes color or becomes cloudy

Active Ingredients (Active ingredients)

Naphazoline HCl (0.02675%)

Pheniramine maleate (0.315%)

Questions Or Comments? (Questions or comments?)

[phone icon] call: 1-800-553-5340

Distributed by:

Bausch & Lomb Americas Inc.

Bridgewater, NJ 08807 USA

When Using This Product (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

Keep Out of Reach of Children. (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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

•
heart disease
•
high blood pressure
•
trouble urinating due to an enlarged prostate gland
•
narrow angle glaucoma

Package/label Principal Display Panel (Package/Label Principal Display Panel)

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

Stop Use and Ask A Doctor If You Experience (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

Advanced Ingredient Data

[{"name": "NAPHAZOLINE", "unii": "H231GF11BV", "classCode": "ACTIB", "strengthNumerator": "0.2675", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENIRAMINE", "unii": "134FM9ZZ6M", "classCode": "ACTIB", "strengthNumerator": "3.15", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BORIC ACID", "unii": "R57ZHV85D4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BORATE", "unii": "91MBZ8H3QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "• temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander", "Purposes": "Redness reliever Antihistamine", "Warnings": "For external use only", "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", "Do not use": "• if you are sensitive to any ingredient in this product • if solution changes color or becomes cloudy", "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", "Active ingredients": "Naphazoline HCl (0.02675%) Pheniramine maleate (0.315%)", "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", "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", "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.", "Ask a doctor before use if you have": "• heart disease • high blood pressure • trouble urinating due to an enlarged prostate gland • narrow angle glaucoma", "Package/Label Principal Display Panel": "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", "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"}

drug facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information