Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 82a99ff3-4f57-42e6-82f4-769d6418be7c

Route

OPHTHALMIC

Published

Effective Date 2020-01-27

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.

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

Questions?

Call: 1-888-309-9030

Other Information

•
store at 20°-25° C (68°-77° F)
•
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.

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

DG health

Allergy

Relief

Eye Drops

Pheniramine

Maleate

0.315% and

Naphazoline

Hydrochloride

0.02675%

Ophthalmic Solution

•
Itching and redness

reliever eye drops
•
Sterile

0.5 FL OZ (15 mL)

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

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

Questions?

Call: 1-888-309-9030

Other Information (Other information)

•
store at 20°-25° C (68°-77° F)
•
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.

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)

DG health

Allergy

Relief

Eye Drops

Pheniramine

Maleate

0.315% and

Naphazoline

Hydrochloride

0.02675%

Ophthalmic Solution

•
Itching and redness

reliever eye drops
•
Sterile

0.5 FL OZ (15 mL)

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", "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", "Questions?": "Call: 1-888-309-9030", "Other information": "• store at 20°-25° C (68°-77° F) • 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.", "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": "DG health Allergy Relief Eye Drops Pheniramine Maleate 0.315% and Naphazoline Hydrochloride 0.02675% Ophthalmic Solution • Itching and redness reliever eye drops • Sterile 0.5 FL OZ (15 mL)", "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: 2026-02-15T11:57:02.642 · Updated: 2026-03-14T22:55:55.934342