Eye Allergy Relief Solution/ Drops
FDA Label NDC 0363-0430

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Eye Allergy Relief (NDC 0363-0430). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if you experience, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Naphazoline HCl (0.02675%)

Pheniramine maleate (0.315%)

Purpose

Redness reliever

Antihistamine

Uses

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

Do Not Use

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

Ask A Doctor Before Use If You Have

  • heart disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • narrow angle glaucoma

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

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

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.

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.

Questions?

Call 1-800-553-5340

9406101

FU55211

DISTRIBUTED BY:

WALGREEN CO.

200 WILMOT RD.,

DEERFIELD, IL 60015

100% SATISFACTION

GUARANTEED

walgreens.com

© 2012 Walgreen Co.

‡Walgreens Pharmacist Survey

Study, November 2012.

Item 156810

UPC – 3 11917 14352 1

ORG1012-R02

Package/Label Principal Display Panel

Well at

Walgreens

WALGREENS PHARMACIST RECOMMENDED‡

STERILE

Eye Allergy

Relief

Pheniramine Maleate

0.315% & Naphazoline

Hydrochloride 0.02675%

Ophthalmic Solution

  • Itching & redness

    reliever eye drops

    • 0.5 FL OZ (15 mL)

* Please review the disclaimer below.