Drugplain

TheraTears 10 mg/mL

carboxymethylcellulose sodium · GEL · MEDTECH PRODUCTS INC

1 Recall on Record
Plain English

TheraTears is a gel containing carboxymethylcellulose sodium at 10 mg/mL, taken ophthalmic. Manufactured by MEDTECH PRODUCTS INC.

Key Facts

Brand Name
TheraTears
Generic Name
carboxymethylcellulose sodium
NDC Code (Product)
58790-003
Manufacturer
MEDTECH PRODUCTS INC
Strength
10 mg/mL
Dosage Form
GEL
Route
OPHTHALMIC
Marketing Status
Application #
M018
Marketing Start
12/07/2018

Recall History

1 Recall on Record
Class II09/08/2021

Akorn, Inc.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective457 reports
macular degeneration356 reports
nausea284 reports
off label use274 reports
pain219 reports
weight decreased210 reports
malaise206 reports
pyrexia198 reports
headache193 reports
infusion related reaction179 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For the temporary relief of burning and irritation due to dryness of the eye. For the temporary relief of discomfort due to minor irritations of the eye or from exposure to wind and sun. For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

Dosage & Administration

Directions To open, twist tab completely off. Instill 1 or 2 drops into affected eye(s) as needed and discard container.

Warnings

Warnings For use in the eyes only. Do not use if solution changes color or becomes cloudy. When using this product ■ do not touch tip of container to any surface to avoid contamination. ■ do not reuse; once opened discard. Stop use and ask a doctor if ■ you experience eye pain, changes in vision, continued redness or irritation of the eye. ■ the 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.

Frequently Asked Questions

What is TheraTears used for?

TheraTears contains carboxymethylcellulose sodium. It is a gel taken ophthalmic. Consult your doctor for specific uses.

Is TheraTears a controlled substance?

TheraTears is not classified as a controlled substance by the DEA.

What is the generic name for TheraTears?

The generic name for TheraTears is carboxymethylcellulose sodium. There are 12 other brand versions of carboxymethylcellulose sodium.

What is the NDC code for TheraTears 10 mg/mL?

The NDC (National Drug Code) for TheraTears 10 mg/mL is 58790-003, listed by MEDTECH PRODUCTS INC.