MAJOR LIQUITEARS- polyvinyl alcohol solution/ drops

Major LiquiTears by

Drug Labeling and Warnings

Major LiquiTears by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                Purpose

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

PURPOSE

Uses

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

WARNINGS

Warnings

Do not use

• if solution changes color or becomes cloudy

WHEN USING

When using this product

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

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

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

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAJOR LIQUITEARS 
polyvinyl alcohol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71205-139(NDC:0904-6492)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990)	POLYVINYL ALCOHOL, UNSPECIFIED	14 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71205-139-15	1 in 1 CARTON	10/01/2018
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	09/17/2015

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	RELABEL(71205-139)