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| Product NDC Code | 50268-066 | ||||
|---|---|---|---|---|---|
| Drug Name | Carboxymethylcellulose sodium |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 579907 | ||||
| Application Number | M018 | ||||
| Labeler Name | AvPAK | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Carboxymethylcellulose sodium 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 Shake well before use. 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 Boric acid, calcium chloride, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride. Stabilized Oxychloro Complex 2.5%. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
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 For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. May be used as a protectant against further irritation.
Purpose
Information about the drug product’s indications for use.Purpose Eye lubricant Uses For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. May be used as a protectant against further irritation.
Spl product data elements
Usually a list of ingredients in a drug product.carboxymethylcellulose sodium Carboxymethylcellulose sodium BORIC ACID CALCIUM CHLORIDE MAGNESIUM CHLORIDE POTASSIUM CHLORIDE WATER SODIUM BORATE SODIUM CHLORIDE CARBOXYMETHYLCELLULOSE SODIUM CARBOXYMETHYLCELLULOSE
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.tu
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
Other information Do Not Use if imprinted seal on cap is torn, broken or missing. Discard 90 days after opening. Store at room temperature 15°-30°C (59°-86°F). Retain outer carton for full product drug information.
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 this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-855-361-3993 Distributed by: AvKARE Pulaski, TN 38478 Rev. 09/2020 AV 09/2020
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 of the eye, or if the 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 use in the eyes only. To avoid contamination, do not touch tip of container to any surface. Replace cap after using. If solution changes color or becomes cloudy, do not use. Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours. Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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