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| Product NDC Code | 63187-298 | ||||
|---|---|---|---|---|---|
| Drug Name | Goodsense artificial tears |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 598050 | ||||
| Application Number | M018 | ||||
| Labeler Name | Proficient Rx LP | ||||
| 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 Each mL contains: Polyvinyl Alcohol 5mg/ml and Povidone 6mg/ml - lubricant
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.Dosage and Administration • 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: Benzalkonium Chloride, Dextrose, Disodium Edetate, Potassium Chloride, Purified Water, Sodium Bicarbonate, Sodium Chloride, Sodium Citrate, Sodium Phosphate (Mono- and Dibasic)
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.Directions • Instill 1 or 2 drops in the affected eye(s) as needed. • Store at 15-25C (59-77F). • Children under 6 years of age: Ask a doctor Dosage and Administration • Instill 1 or 2 drops in the affected eye(s) as needed.
Purpose
Information about the drug product’s indications for use.Uses • temporary relieves burning and irritations due to dryness of the eye(s) • protects against further irritation
Spl product data elements
Usually a list of ingredients in a drug product.GOODSENSE ARTIFICIAL TEARS POLYVINYL ALCOHOL POLYVINYL ALCOHOL, UNSPECIFIED POLYVINYL ALCOHOL POVIDONE, UNSPECIFIED POVIDONE BENZALKONIUM CHLORIDE DEXTROSE, UNSPECIFIED FORM EDETATE DISODIUM POTASSIUM CHLORIDE WATER SODIUM BICARBONATE SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM 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.Relabeled By: Proficient Rx LP Thousand Oaks, CA 91320 63187-298-15
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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 feel eye pain • changes in vision occur • redness or irritation of the eye gets worse or lasts more than 72 hours
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product • remove contact lenses before using • do not touch tip of container to any surface to avoid contamination • replace cap after each use
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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. Do not use if solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product.
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