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Theratears - Medication Information

Product NDC Code 58790-003
Drug Name

Theratears

Type Brand
Active Ingredients
Carboxymethylcellulose sodium, unspecified form 10 mg/ml
Route OPHTHALMIC
Dosage Form GEL
RxCUI drug identifier 579907,
998666
Application Number part349
Labeler Name MEDTECH PRODUCTS INC
Packages
Package NDC Code Description
58790-003-30 6 pouch in 1 carton (58790-003-30) / 5 vial in 1 pouch / .6 ml in 1 vial
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (In each unit dose) sodium carboxymethylcellulose 1%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions To open, twist tab completely off. Instill 1 or 2 drops in the affected eye(s) as needed.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Borate buffers, calcium chloride, magnesium chloride, potassium chloride, purified water, sodium bicarbonate, sodium chloride and sodium phosphate Questions or comments? 1-800-579-8327

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses As a lubricant to relieve dryness of the eye. As a protectant against further irritation of the eye. For temporary relief of burning, irritation, and discomfort including exposure to wind or sun.

Purpose

Information about the drug product’s indications for use.
Purpose Eye lubricant

Spl product data elements

Usually a list of ingredients in a drug product.
TheraTears carboxymethylcellulose sodium carboxymethylcellulose sodium, unspecified form carboxymethylcellulose boric acid sodium borate calcium chloride magnesium chloride potassium chloride water sodium bicarbonate sodium chloride sodium phosphate TheraTears carboxymethylcellulose sodium carboxymethylcellulose sodium, unspecified form carboxymethylcellulose boric acid sodium borate calcium chloride magnesium chloride potassium chloride water sodium bicarbonate sodium chloride sodium phosphate

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel Text for Carton Label: PRESERVATIVE FREE RECOMMENDED DOCTOR CREATED thera tears® THERAPY FOR YOUR EYES® Liquid Gel nighttime dry eye therapy LUBRICANT EYE GEL SOOTHING OVERNIGHT RELIEF 30 STERILE Single-Use Vials* 0.60 FL OZ (18.0 mL) TOTAL PRESERVATIVE FREE RECOMMENDED DOCTOR CREATED thera tears® THERAPY FOR YOUR EYES® Liquid Gel nighttime dry eye therapy LUBRICANT EYE GEL SOOTHING OVERNIGHT RELIEF 30 STERILE Single-Use Vials* 0.60 FL OZ (18.0 mL) TOTAL Principal Display Panel Text for Carton Label: PRESERVATIVE FREE RECOMMENDED DOCTOR CREATED thera tears® THERAPY FOR YOUR EYES® Liquid Gel nighttime dry eye therapy LUBRICANT EYE GEL SOOTHING OVERNIGHT RELIEF 4 Single-Use Vials 0.08 FL OZ (2.4 mL) TOTAL PRESERVATIVE FREE RECOMMENDED DOCTOR CREATED thera tears® THERAPY FOR YOUR EYES® Liquid Gel nighttime dry eye therapy LUBRICANT EYE GEL SOOTHING OVERNIGHT RELIEF 4 Single-Use Vials 0.08 FL OZ (2.4 mL) TOTAL

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use If solution changes color or becomes cloudy.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information Use only if foil pouch is sealed and single-use container is intact. Do not touch unit-dose tip to eye.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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 be 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 immediately.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API