drug facts

drug facts

SPL v3

SPL

SPL Set ID 253130b4-a23b-43a0-b125-0fa5bd01b2b6

Route

ophthalmic

Published

Effective Date 2020-03-04

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 water sodium borate sodium chloride hydrochloric acid hypromellose, unspecified

Identifiers & Packaging

Marketing Status

nda active Since 2017-02-01

Purpose

Redness reliever Antihistamine

Description

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

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)
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%)

Questions?

Call: 1-866-767-9161

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%)

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

CVS

Health _TM

Eye Allergy Relief

pheniramine maleate 0.315%

Naphazoline hydrochloride 0.02675%

EYE DROPS

Relieves itching & redness caused by :

Pollen, grass & ragweed
Animal hair & dander

TWIN

PACK

[two bottle icon]

[teardrop icon]

Actual Product

Size on Side Panel

STERILE

2 BOTTLES

0.5 FL OZ (15 ml) 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

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 (Other information)

store at 20°-25°C (68°-77°F)
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.

Questions?

Call: 1-866-767-9161

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

Naphazoline HCl (0.02675%)

Pheniramine maleate (0.315%)

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)

CVS

Health _TM

Eye Allergy Relief

pheniramine maleate 0.315%

Naphazoline hydrochloride 0.02675%

EYE DROPS

Relieves itching & redness caused by :

Pollen, grass & ragweed
Animal hair & dander

TWIN

PACK

[two bottle icon]

[teardrop icon]

Actual Product

Size on Side Panel

STERILE

2 BOTTLES

0.5 FL OZ (15 ml) 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

[{"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": ""}, {"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"}]

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", "Questions?": "Call: 1-866-767-9161", "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": "CVS Health TM Eye Allergy Relief pheniramine maleate 0.315% Naphazoline hydrochloride 0.02675% EYE DROPS Relieves itching & redness caused by : Pollen, grass & ragweed Animal hair & dander TWIN PACK [two bottle icon] [teardrop icon] Actual Product Size on Side Panel STERILE 2 BOTTLES 0.5 FL OZ (15 ml) 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: 2026-02-15T12:08:13.720484 · Updated: 2026-03-14T23:12:24.385926