TheraTears Extra
Carboxymethylcellulose Sodium, Unspecified Form · Solution/ Drops · Ophthalmic
Active ingredient
Active ingredient Sodium carboxymethylcellulose 0.25%
Purpose
Purpose Eye lubricant
Uses
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
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.
Do not use
Do not use if solution changes color or becomes cloudy.
Stop use and ask a doctor
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
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Directions To open, twist tab completely off. Instill 1 or 2 drops of TheraTears® EXTRA® in the affected eye(s) as needed
Inactive ingredients
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?
Questions or comments? 1-800-579-8327
Label text from the FDA structured product label by MEDTECH PRODUCTS INC (revised Dec 13, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Carboxymethylcellulose Sodium, Unspecified Form in 1 product
- Carboxymethylcellulose Sodium, Unspecified in 1 product
TheraTears Extra NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 58790-007 | Carboxymethylcellulose Sodium, Unspecified Form 2.5 mg/mL Solution/ Drops | MEDTECH PRODUCTS INC | OTC MONOGRAPH DRUG |
| 58790-010 | Carboxymethylcellulose Sodium, Unspecified 2.5 mg/mL Solution/ Drops | MEDTECH PRODUCTS INC | OTC MONOGRAPH DRUG |
TheraTears Extra recalls
- D-0717-2022 Mar 30, 2022 · Class II · Terminated
Lack of Assurance of Sterility
Frequently asked questions
What is TheraTears Extra used for?
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.
Who makes TheraTears Extra?
TheraTears Extra is listed by 1 labeler in the FDA NDC directory, including MEDTECH PRODUCTS INC.
Has TheraTears Extra been recalled?
The FDA enforcement database lists 1 recall for TheraTears Extra, most recently D-0717-2022 (class ii): Lack of Assurance of Sterility