TheraTears Extra

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 Extra
Active ingredientCarboxymethylcellulose Sodium, Unspecified Form
Label structure10 sections

Indications and uses

• For use as a protectant against further irritation or to relieve dryness of the eye. • For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

Dosage and administration

Instill 1 or 2 drops of TheraTears ® Extra in the affected eye(s) as needed.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium carboxymethylcellulose 0.25%

Purpose

OTC - PURPOSE SECTION

Eye lubricant

Uses

INDICATIONS & USAGE SECTION

  • For use as a protectant against further irritation or to relieve dryness of the eye.
  • For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Instill 1 or 2 drops of TheraTears® Extra in the affected eye(s) as needed.

Other information

OTHER SAFETY INFORMATION

  • Do not use if neck ring is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Boric acid, calcium chloride, Dequest®, potassium chloride, sodium bicarbonate, sodium borate, sodium chloride, magnesium chloride, sodium perborate, sodium phosphate, trehalose, and water for injection.

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®

EXTRA

dry eye therapy

LUBRICANT

EYE DROPS

STERILE

0.5 FL OZ (15mL)

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:

new!

RECOMMENDED

DOCTOR

CREATED

thera

tears®

THERAPY FOR YOUR EYES®

EXTRA

dry eye therapy

LUBRICANT

EYE DROPS

EXTRA MOISTURIZING

√ Rehydrates

√ Protects

√ Supports pH Level

STERILE

Multi-Use

Bottle* 0.5 FL OZ (15mL)

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 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76688-00276688-002-70, 76688-002-72

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
75f63b76-4b15-4c79-a191-290b8b697dd85870d78c-4ac5-4dc3-bf66-2aaac7dc504a2020-10-19WarningsExact identifier
spl id: 75f63b76-4b15-4c79-a191-290b8b697dd8
spl set id: 5870d78c-4ac5-4dc3-bf66-2aaac7dc504a

Reported adverse events (FAERS/openFDA)#

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