TheraTears Lubricant

Manufacturer
Akorn AG | Akorn Operating Company LLC
Effective date
2020-10-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:10:41

Label at a glance#

ProductTheraTears Lubricant
Active ingredientCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
Label structure11 sections

Indications and uses

• As a lubricant to relieve dryness of the eye. • As a protectant against further irritation of the eye. • For temporary relief of burning, irritation, and discomfort including exposure to wind or sun.

Dosage and administration

Instill 1 or 2 drops in the affected eye(s) as needed.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium carboxy- methylcellulose 0.25%

Purpose

OTC - PURPOSE SECTION

Eye lubricant

Uses

INDICATIONS & USAGE SECTION

  • As a lubricant to relieve dryness of the eye.
  • As a protectant against further irritation of the eye.
  • For temporary relief of burning, irritation, and discomfort including exposure to wind or sun.

Warnings

WARNINGS SECTION

For external use only

  • To avoid contamination do not touch tip of opened container to any surface. Replace cap after using.

Do not use

OTC - DO NOT USE SECTION

  • If solution changes color or becomes cloudy.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • You experience eye pain, changes in vision, continued redness or irritation.
  • 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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

OTHER SAFETY INFORMATION

  • Do not use if imprinted neckband is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Borate buffers, calcium chloride, Dequest®, magnesium chloride, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium perborate, and sodium phosphate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-579-8327

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

thera

tears®

THERAPY FOR YOUR EYES™

dry eye therapy

LUBRICANT

EYE DROPS

STERILE

1 FL OZ (30 mL)

Principal Display Panel Text for Container Label
Principal Display Panel Text for Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

VALUE SIZE

RECOMMENDED

DOCTOR

CREATED

thera

tears®

THERAPY FOR YOUR EYES®

dry eye therapy

LUBRICANT

EYE DROPS

IMMEDIATE

LONG LASTING

RELIEF

STERILE

Multi-Use Bottle*

1 FL OZ (30 mL)

Principal Display Panel Text for Carton Label
Principal Display Panel Text for Carton Label

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76688-00176688-001-30, 76688-001-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML · Source PDF

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5fd3b20c-970c-4541-8133-336a8047100f56d2dea5-26c0-4612-a0f3-88ab4d4b93ee2020-10-19WarningsExact identifier
spl id: 5fd3b20c-970c-4541-8133-336a8047100f
spl set id: 56d2dea5-26c0-4612-a0f3-88ab4d4b93ee

Reported adverse events (FAERS/openFDA)#

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