Eye Allergy Relief Solution/ Drops
FDA Label NDC 49035-430

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc for the product Eye Allergy Relief (NDC 49035-430). 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, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if you experience, 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.

Warnings

For external use only

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:1-888-287-1915

1 – 0.5 FL OZ in 1 box

9382801

GE55211

2 – 0.5 FL OZ in 1 box

9482801

GE55299

DISTRIBUTED BY:

Wal-Mart Stores, Inc.,

Bentonville, AR 72716

Package/Label Principal Display Panel

NDC 49035-430-15

equate™

Quality
Guaranteed

Eye Allergy
Relief Drops

Pheniramine Maleate 0.315% and
Naphazoline Hydrochloride
0.02675% Ophthalmic Solution

Itching and Redness
Reliever Eye Drops

Sterile

0.5 FL OZ (15mL)

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