FDA.reportPublic FDA data

TheraTears Extra PF 58790-010

Manufacturer
MEDTECH PRODUCTS INC
Effective date
2026-10-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-10-20 03:01:45

Label at a glance#

ProductTheraTears Extra
Active ingredientCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
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

To open,  twist  tab completely off. Instill 1 or 2 drops of TheraTears® EXTRA® in the affected eye(s) as needed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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.
    Do not reuse. Once opened discard. Use individual vials within 90 days of opening foil pouch.
  • This product contains no preservatives. Any solution not used immediately after opening should he discarded. Re-use of this single-use product may lead to inflammation of the eye and/or discomfort, based on potential contamination during handling.

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

  • To open,  twist tab completely off.
  • Instill 1 or 2 drops of TheraTears® EXTRA® in the affected eye(s) as needed

Other information

OTHER SAFETY INFORMATION

  • Store between 15C - 25C (59F - 77F)
  • Do not touch unit-dose tip to eye.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Boric acid, calcium chloride, hydrochloric acid*, magnesium chloride, potassium chloride, sodium bicarbonate, sodium borate, sodium chloride, sodium hydroxide*, sodium phosphate, trehalose, and water. *May contain these ingredients to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-579-8327

Principal Display Panel Text for Carton Label:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRESERVATIVE

FREE

RECOMMENDED

DOCTOR

CREATED

thera

tears®

EXTRA®

Carboxymethylcellulose sodium 0.25%

Lubricant Eye Drops

Dry & Itchy

dry eye therapy

30 STERILE

Single-Use Vials 0.6 FL OZ (18 mL) TOTAL

TT Extra PF LabelTT Extra PF Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
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7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58790-010-30EA - Each58790-010c7a1969e-383d-4955-884d-5c381cf4409412023-02-06

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
58790-01058790-010-30

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311ACTIB
BORIC ACIDR57ZHV85D4IACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
HYDROCHLORIC ACIDQTT17582CBIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POTASSIUM CHLORIDE660YQ98I10IACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM PHOSPHATESE337SVY37IACT
TREHALOSEB8WCK70T7IIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-12-13full-release2026-06-01 00:42:11

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
TheraTears ExtraCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDMEDTECH PRODUCTS INCf1845041-9d8d-42a0-a2cb-68def7a5aac72024-12-13WarningsExact identifier
ndc (package): 58790-010-30
ndc (product): 58790-010
ndc11 (package): 58790001030
spl set id: f1845041-9d8d-42a0-a2cb-68def7a5aac7

Reported adverse events (FAERS/openFDA)#

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