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.
TheraTears Extra
- Manufacturer
- MEDTECH PRODUCTS INC
- Effective date
- 2024-12-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:42:11
Label at a glance#
ProductTheraTears Extra
Active ingredientCarboxymethylcellulose Sodium, Unspecified
Label structure10 sections
Dosage and administration
To open, twist tab completely off. Instill 1 or 2 drops of TheraTears® EXTRA® in the affected eye(s) as needed
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient
Sodium carboxymethylcellulose 0.25%
Purpose
Eye lubricant
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.
Warnings
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
- if solution changes color or becomes cloudy.
Stop use and ask a doctor if
- 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.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- To open, twist tab completely off.
- Instill 1 or 2 drops of TheraTears® EXTRA® in the affected eye(s) as needed
Other information
- Use only if foil pouch is sealed and single-use container is intact.
- Do not touch unit-dose tip to eye.
Inactive ingredients
Boric acid, calcium chloride, hydrochloric acid*, magnesium chloride, potassium chloride, sodium bicarbonate, sodium borate, sodium chloride, sodium hydroxide*, sodium phosphate, trehalose, and water for injection. *May contain these ingredients to adjust pH.
Questions or comments?
1-800-579-8327
Principal Display Panel Text for Carton Label:
PRESERVATIVE
FREE
RECOMMENDED
DOCTOR
CREATED
thera
tears®
THERAPY FOR YOUR EYES®
EXTRA®
dry eye therapy
LUBRICANT
EYE DROPS
EXTRA MOISTURIZING
√ Rehydrates
√ Protects
√ Supports pH Level
30 STERILE
Single-Use Vials 0.60 FL OZ (18.0 mL) TOTAL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1547948 | carboxymethylcellulose sodium 0.25 % Ophthalmic Solution | PSN | 4 |
| 2106821 | TheraTears 0.25 % Ophthalmic Solution | PSN | 4 |
| 2106821 | carboxymethylcellulose sodium 2.5 MG/ML Ophthalmic Solution [TheraTears] | SBD | 4 |
| 1547948 | carboxymethylcellulose sodium 2.5 MG/ML Ophthalmic Solution | SCD | 4 |
| 1547948 | carboxymethylcellulose sodium 0.25 % Ophthalmic Solution | SY | 4 |
| 2106821 | TheraTears 0.25 % Ophthalmic Solution | SY | 4 |
| 2106821 | TheraTears 2.5 MG/ML Ophthalmic Solution | SY | 4 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58790-010-30 | TheraTears Extra | 5 in 1 POUCH | SOLUTION/ DROPS | 5 | 4 | |
| 58790-010-30 | TheraTears Extra | 6 in 1 CARTON | SOLUTION/ DROPS | 6 | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58790-010-30 | EA - Each | 58790-010 | c7a1969e-383d-4955-884d-5c381cf44094 | 1 | 2023-02-06 |
Products#
Every source-derived product name is available through these pages.
- TheraTears Extra
- Carboxymethylcellulose Sodium, Unspecified
- Carboxymethylcellulose
- Boric Acid
- calcium chloride
- hydrochloric acid
- magnesium chloride
- potassium chloride
- sodium bicarbonate
- sodium borate
- sodium chloride
- sodium hydroxide
- sodium phosphate
- trehalose
- water
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58790-010 | 58790-010-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Carboxymethylcellulose Sodium, Unspecified | K679OBS311 | ACTIB |
| Boric Acid | R57ZHV85D4 | IACT |
| calcium chloride | M4I0D6VV5M | IACT |
| hydrochloric acid | QTT17582CB | IACT |
| magnesium chloride | 02F3473H9O | IACT |
| potassium chloride | 660YQ98I10 | IACT |
| sodium bicarbonate | 8MDF5V39QO | IACT |
| sodium borate | 91MBZ8H3QO | IACT |
| sodium chloride | 451W47IQ8X | IACT |
| sodium hydroxide | 55X04QC32I | IACT |
| sodium phosphate | SE337SVY37 | IACT |
| trehalose | B8WCK70T7I | IACT |
| water | 059QF0KO0R | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| TheraTears Extra | CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED | MEDTECH PRODUCTS INC | f1845041-9d8d-42a0-a2cb-68def7a5aac7 | 2024-12-13 | Warnings | 58790-010-30 58790-010 58790001030 ca0d40e7-168e-40a9-8df0-3e8958cdb7cf f1845041-9d8d-42a0-a2cb-68def7a5aac7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.