Drug Facts

Drug Facts

SPL v15

SPL

SPL Set ID df40c426-ef66-4688-b5b5-c6fc5556e9a8

Route

OPHTHALMIC

Published

Effective Date 2023-10-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Naphazoline (0.25 mg) Pheniramine (3 mg)

Inactive Ingredients

Benzalkonium Chloride Boric Acid Edetate Disodium Water Sodium Borate Sodium Chloride Sodium Hydroxide Hydrochloric Acid

Identifiers & Packaging

Marketing Status

NDA Active Since 1994-06-08

Description

Active ingredients Purpose Naphazoline hydrochloride 0.025% Redness reliever Pheniramine maleate 0.3% Antihistamine

How Supplied

Product: 50090-0185 NDC: 50090-0185-0 15 mL in a BOTTLE / 1 in a CARTON

Medication Information

How Supplied

Product: 50090-0185

NDC: 50090-0185-0 15 mL in a BOTTLE / 1 in a CARTON

Description

Active ingredients Purpose Naphazoline hydrochloride 0.025% Redness reliever Pheniramine maleate 0.3% Antihistamine

Uses

for the temporary relief of redness and itching of the eye(s) due to:

ragweed
pollen
grass
animal dander and hair

Section 55105-1

Active ingredients	Purpose
Naphazoline hydrochloride 0.025%	Redness reliever
Pheniramine maleate 0.3%	Antihistamine

Warnings

For external use only

Directions

adults and children 6 years and over: put 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 this solution changes color or becomes cloudy

Questions?

In the U.S. call 1-800-757-9195 or visit www.alcon.com

Other Information

store at 20°-25°C (68°-77°F)
protect from light

Inactive Ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride, sodium hydroxide and/or hydrochloric acid

When Using This Product

pupils may become enlarged temporarily causing light sensitivity
overuse may cause more eye redness
remove contact lenses before using
to avoid contamination, do not touch tip of container to any surface
replace cap after each use

Stop Use and Ask A Doctor If

you feel eye pain
changes in vision occur
redness or irritation of the eye(s) gets worse or lasts more than 72 hours

Keep Out of the Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away. Accidental swallowing by infants and children may lead to coma and marked reduction in body temperature.

Ask A Doctor Before Use If You Have

narrow angle glaucoma
heart disease
high blood pressure
trouble urinating

Naphazoline Hydrochloride and Pheniramine Maleate

Structured Label Content

Uses

for the temporary relief of redness and itching of the eye(s) due to:

ragweed
pollen
grass
animal dander and hair

Section 55105-1 (55105-1)

Active ingredients	Purpose
Naphazoline hydrochloride 0.025%	Redness reliever
Pheniramine maleate 0.3%	Antihistamine

Warnings

For external use only

Directions

adults and children 6 years and over: put 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 this solution changes color or becomes cloudy

Questions?

In the U.S. call 1-800-757-9195 or visit www.alcon.com

How Supplied (HOW SUPPLIED)

Product: 50090-0185

NDC: 50090-0185-0 15 mL in a BOTTLE / 1 in a CARTON

Other Information (Other information)

store at 20°-25°C (68°-77°F)
protect from light

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride, sodium hydroxide and/or hydrochloric acid

When Using This Product (When using this product)

pupils may become enlarged temporarily causing light sensitivity
overuse may cause more eye redness
remove contact lenses before using
to avoid contamination, do not touch tip of container to any surface
replace cap after each use

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you feel eye pain
changes in vision occur
redness or irritation of the eye(s) gets worse or lasts more than 72 hours

Keep Out of the Reach of Children. (Keep out of the reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away. Accidental swallowing by 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)

narrow angle glaucoma
heart disease
high blood pressure
trouble urinating

Naphazoline Hydrochloride and Pheniramine Maleate (naphazoline hydrochloride and pheniramine maleate)

Advanced Ingredient Data

[{"name": "NAPHAZOLINE", "unii": "H231GF11BV", "classCode": "ACTIB", "strengthNumerator": "0.25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENIRAMINE", "unii": "134FM9ZZ6M", "classCode": "ACTIB", "strengthNumerator": "3", "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": "Sodium Hydroxide", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Hydrochloric Acid", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the temporary relief of redness and itching of the eye(s) due to: ragweed pollen grass animal dander and hair", "55105-1": "Active ingredients Purpose Naphazoline hydrochloride 0.025% Redness reliever Pheniramine maleate 0.3% Antihistamine", "Warnings": "For external use only", "Directions": "adults and children 6 years and over: put 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 this solution changes color or becomes cloudy", "Questions?": "In the U.S. call 1-800-757-9195 or visit www.alcon.com", "HOW SUPPLIED": "Product: 50090-0185 NDC: 50090-0185-0 15 mL in a BOTTLE / 1 in a CARTON", "Other information": "store at 20°-25°C (68°-77°F) protect from light", "Inactive ingredients": "benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride, sodium hydroxide and/or hydrochloric acid", "When using this product": "pupils may become enlarged temporarily causing light sensitivity overuse may cause more eye redness remove contact lenses before using to avoid contamination, do not touch tip of container to any surface replace cap after each use", "Stop use and ask a doctor if": "you feel eye pain changes in vision occur redness or irritation of the eye(s) gets worse or lasts more than 72 hours", "Keep out of the reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away. Accidental swallowing by infants and children may lead to coma and marked reduction in body temperature.", "Ask a doctor before use if you have": "narrow angle glaucoma heart disease high blood pressure trouble urinating"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:06.323713 · Updated: 2026-03-14T23:01:32.010994