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| Product NDC Code | 50268-043 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Artificial tears |
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| Type | Generic | ||||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Intravascular Volume [PE], Non-Standardized Chemical Allergen [EPC], Osmotic Activity [MoA], Plasma Volume Expander [EPC] |
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| Active Ingredients |
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| Route | OPHTHALMIC | ||||||
| Dosage Form | SOLUTION/ DROPS | ||||||
| RxCUI drug identifier | 900138 | ||||||
| Application Number | M018 | ||||||
| Labeler Name | AvPAK | ||||||
| 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 ingredients Purpose Dextran 70 0.1% Lubricant Glycerin 0.2% Lubricant Hypromellose 0.3% Lubricant
| Dextran 70 0.1% | Lubricant |
| Glycerin 0.2% | Lubricant |
| Hypromellose 0.3% | 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.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: benzalkonium chloride, boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc chloride.
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.Active ingredients Purpose Dextran 70 0.1% Lubricant Glycerin 0.2% Lubricant Hypromellose 0.3% Lubricant
| Dextran 70 0.1% | Lubricant |
| Glycerin 0.2% | Lubricant |
| Hypromellose 0.3% | Lubricant |
Spl product data elements
Usually a list of ingredients in a drug product.Artificial Tears Artificial Tears BORIC ACID CALCIUM CHLORIDE GLYCINE MAGNESIUM CHLORIDE POLYSORBATE 80 POTASSIUM CHLORIDE WATER SODIUM CHLORIDE ZINC CHLORIDE DEXTRAN 70 DEXTRAN 70 GLYCERIN GLYCERIN HYPROMELLOSES HYPROMELLOSES BENZALKONIUM CHLORIDE
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 15
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 this 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 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? 1-855-361-3993 Distributed by: AvKARE Pulaski, TN 38478 www.avkare.com Rev. 12/2022 AV 12/2022
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 any of the following: You experience eye pain, changes in vision, continued redness and irritation of the eye The condition worsens or persists for 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 Avoid contamination, do not touch tip of container to any surface Replace cap after use
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at room temperature
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
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