Drug Facts

Drug Facts

SPL v5

SPL

SPL Set ID 6043040e-3206-40dd-aa87-940b1a84a496

Route

OPHTHALMIC

Published

Effective Date 2024-07-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Naphazoline (0.2675 mg) Pheniramine (3.15 mg)

Inactive Ingredients

Benzalkonium Chloride Boric Acid Edetate Disodium Hypromellose, Unspecified Water Sodium Borate Sodium Chloride Hydrochloric Acid

Identifiers & Packaging

Marketing Status

NDA Active Since 2015-07-01

Description

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

Purpose

Redness reliever Antihistamine

Medication Information

Purpose

Redness reliever

Antihistamine

Description

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

Uses

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

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: 1-866-767-8975

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

Compare to Opcon-A®

active ingredients*

NDC 11822-0552-2

EYE ALLERGY

RELIEF DROPS

pheniramine maleate 0.315% and

naphazoline hydrochloride 0.02675%

ophthalmic solution

ANTIHISTAMINE AND

REDNESS RELIEVER

STERILE

2 ×15 mL BOTTLES

(0.5 FL OZ EACH)

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

Uses

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

Purpose

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 (Do not use)

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

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

Active Ingredients (Active ingredients)

Naphazoline HCl (0.02675%)

Pheniramine maleate (0.315%)

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.

Questions Or Comments? (Questions or comments?)

{phone icon} call: 1-866-767-8975

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

Compare to Opcon-A®

active ingredients*

NDC 11822-0552-2

EYE ALLERGY

RELIEF DROPS

pheniramine maleate 0.315% and

naphazoline hydrochloride 0.02675%

ophthalmic solution

ANTIHISTAMINE AND

REDNESS RELIEVER

STERILE

2 ×15 mL BOTTLES

(0.5 FL OZ EACH)

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

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander", "Purpose": "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: 1-866-767-8975", "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 Compare to Opcon-A® active ingredients* NDC 11822-0552-2 EYE ALLERGY RELIEF DROPS pheniramine maleate 0.315% and naphazoline hydrochloride 0.02675% ophthalmic solution ANTIHISTAMINE AND REDNESS RELIEVER STERILE 2 × 15 mL BOTTLES (0.5 FL OZ EACH)", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:19.668880 · Updated: 2026-03-14T23:03:20.235753