Drug Facts

Drug Facts
SPL v10
SPL
SPL Set ID 806ad1b6-0de7-4e9a-be86-475c0ef2c340
Route
OPHTHALMIC
Published
Effective Date 2025-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

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 2010-08-31

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: 1-800-910-6874

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

NDC 11673-430-15

Compare to

Opcon-A® active ingredient*

Eye Allergy

Relief Drops

pheniramine maleate 0.315%

and naphazoline

hydrochloride 0.02675%

ophthalmic solution

ANTIHISTAMINE AND

REDNESS RELIEVER

Relieves itching and

redness caused by grass,

ragweed, pollen, animal

hair and dander

[arrow icon] up&up™

STERILE 0.5 FL OZ (15 mL) 9383104

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: 1-800-910-6874

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)

NDC 11673-430-15

Compare to

Opcon-A® active ingredient*

Eye Allergy

Relief Drops

pheniramine maleate 0.315%

and naphazoline

hydrochloride 0.02675%

ophthalmic solution

ANTIHISTAMINE AND

REDNESS RELIEVER

Relieves itching and

redness caused by grass,

ragweed, pollen, animal

hair and dander

[arrow icon] up&up™

STERILE 0.5 FL OZ (15 mL) 9383104

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


Raw Label Data

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