Label at a glance#

ProductMajor LiquiTears

Active ingredientPOLYVINYL ALCOHOL

Label structure12 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

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

OTC - PURPOSE SECTION

Uses

to prevent further irritation
to relieve dryness of the eye

WARNINGS SECTION

Warnings

Do not use

if solution changes color or becomes cloudy

OTC - WHEN USING SECTION

When using this product

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

OTC - ASK DOCTOR SECTION

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 SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Directions

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

STORAGE AND HANDLING SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

DOSAGE & ADMINISTRATION SECTION

Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA

Made in Korea

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-3158

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

Polyvinyl Alcohol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
142004	polyvinyl alcohol 1.4 % Ophthalmic Solution	PSN	3
142004	polyvinyl alcohol 0.014 ML/ML Ophthalmic Solution	SCD	3
142004	polyvinyl alcohol 1.4 % Ophthalmic Solution	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-3158-0	2023-01-30	C162847	48780-1	f386c64a-18bf-0266-e053-dadaa90a7c1a	79ebe079-e006-4157-9efb-9aadae21e00d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-3158-0	Major LiquiTears	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15		3
50090-3158-0	Major LiquiTears	1 in 1 CARTON	SOLUTION/ DROPS	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3158	MAJOR LIQUITEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]	3	Legacy NDC, 2 package rows	20200122_79ebe079-e006-4157-9efb-9aadae21e00d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3158-0	ML - Milliliter	50090-3158	40040aae-13c8-4b45-afa6-96e386c9c529	1	2018-11-06
0904-6492-35	ML - Milliliter	0904-6492	3fb2a351-7d18-4e12-b3ee-678265a72cd3	1	2016-02-04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Major LiquiTears
Polyvinyl Alcohol
BENZALKONIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE
EDETATE DISODIUM
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
WATER
SODIUM CHLORIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50090-3158	50090-3158-0
0904-6492

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POLYVINYL ALCOHOL	532B59J990	ACTIB
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE	BWZ7K44R51	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	5QWK665956	IACT
WATER	059QF0KO0R	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
9fe23aa0-e8f1-4908-ab44-3ec351a935fc			79ebe079-e006-4157-9efb-9aadae21e00d	2020-01-18	Warnings	Exact identifier spl id: 9fe23aa0-e8f1-4908-ab44-3ec351a935fc spl set id: 79ebe079-e006-4157-9efb-9aadae21e00d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.