Major Liquitears
FDA Label NDC 50090-3158

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Major Liquitears (NDC 50090-3158). 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 otc - active ingredient, otc - purpose, warnings, otc - when using, otc - ask doctor, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                Purpose

Polyvinyl Alcohol 1.4%..................................... Lubricant

Otc - Purpose

Uses

  • to prevent further irritation
  • to relieve dryness of the eye

Warnings

Warnings

Do not use

  • if solution changes color or becomes cloudy

Otc - When Using

When using this product

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Otc - Ask Doctor

Stop use and ask a doctor if

  • you experience eye pain, changes in vision, continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours

Otc - 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.

Indications & Usage

Directions

  • instill 1 to 2 drops in the affected eye(s) as needed

Storage And Handling

Other information

  • store at 15°-25°C (59°-77°F)
  • keep tightly closed

Inactive Ingredient

Inactive ingredients

benzalkonium chloride, dibasic sodium phosphate hydrate, edetate disodium hydrate, monobasic sodium phosphate dihydrate, purified water, sodium chloride

Dosage & Administration

Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA


Made in Korea

How Supplied

Product: 50090-3158

NDC: 50090-3158-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON

* Please review the disclaimer below.