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| Product NDC Code | 58790-000 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Theratears lubricant |
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| Type | Brand | ||||||||||||
| Active Ingredients |
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| Route | OPHTHALMIC | ||||||||||||
| Dosage Form | SOLUTION/ DROPS | ||||||||||||
| RxCUI drug identifier | 1547948, 2106821 |
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| Application Number | part349 | ||||||||||||
| Labeler Name | MEDTECH PRODUCTS INC | ||||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (In each unit dose) Sodium Carboxymethylcellulose 0.25%
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
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 Lubricant 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 PRESERVATIVE FREE thera tears® THERAPY FOR YOUR EYES TM dry eye therapy LUBRICANT EYE DROPS IMMEDIATE LONG LASTING RELIEF 30 STERILE Single-Use Vials 0.60 FL OZ (18.0mL) TOTAL Principal Display Panel PRESERVATIVE FREE thera tears® THERAPY FOR YOUR EYES TM dry eye therapy LUBRICANT EYE DROPS IMMEDIATE LONG LASTING RELIEF 30 STERILE Single-Use Vials 0.60 FL OZ (18.0mL) 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.THERATEARS LUBRICANT- carboxymethylcellulose sodium solution/ drops Medtech Products Inc., a Prestige Consumer Healthcare company Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions and comments? 1-800-579-8327
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 ptential 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