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Product NDC Code | 59390-183 | ||||
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Drug Name | Altachlore sodium chloride hypertonicity |
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Type | Brand | ||||
Pharm Class | Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC] |
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Active Ingredients |
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Route | OPHTHALMIC | ||||
Dosage Form | SOLUTION/ DROPS | ||||
RxCUI drug identifier | 730780 | ||||
Application Number | M018 | ||||
Labeler Name | Altaire Pharmaceuticals Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Sodium Chloride 5%
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 instill 1 or 2 drops in the affected eye(s) every 3 to 4 hours, or as directed by a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Boric Acid, Hypromellose, Methylparaben, Propylene Glycol, Proplyparaben, Sodium Borate, and Water for injection. Sodium Hydroxide and/or Hydrochloric Acid may be added 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.Use For the temporary relief of corneal edema.
Purpose
Information about the drug product’s indications for use.Purpose Hypertonicity Agent
Spl product data elements
Usually a list of ingredients in a drug product.Altachlore Sodium Chloride Hypertonicity Sodium Chloride BORIC ACID HYPROMELLOSE, UNSPECIFIED METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN SODIUM BORATE WATER SODIUM HYDROXIDE HYDROCHLORIC ACID SODIUM CHLORIDE SODIUM CATION
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 iSolutions ActivEyes Altachlore 5% Solution Sodium Chloride Hypertonicity Ophthalmic Solution 5% Sterile 15mL NET WT (1/2 FL OZ) PRINCIPAL DISPLAY PANEL iSolutions ActivEyes Altachlore 5% Solution Sodium Chloride Hypertonicity Ophthalmic Solution 5% Sterile 15mL NET WT (1/2 FL OZ)
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.iSolutions ActivEyes Altachlore 5% Solution Sodium Chloride Hypertonicity Ophthalmic Solution 5% 15mL NDC 59390- 183-13 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 except under the advice and supervision of a doctor. 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 right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information replace cap after using and keep tightly closed. store at 15° to 30°C (59° to 86°F). remove contact lenses before using.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1 (800) 258-2471 9am– 5pm EST Monday - Friday
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 your vision occur. continued redness or irritation of the eye persists. condition worsens or persists.
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 keep tightly closed. to avoid contamination, do not touch tip of container to any surface. replace cap immediately after each use. this product may cause temporary burning and irritation on being instilled into the eye.
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 Save box for complete information Do not use except under the advice and supervision of a doctor. if solution changes color or becomes cloudy. When using this product keep tightly closed. to avoid contamination, do not touch tip of container to any surface. replace cap immediately after each use. this product may cause temporary burning and irritation on being instilled into the eye. Stop use and ask a doctor if you experience eye pain. changes in your vision occur. continued redness or irritation of the eye persists. condition worsens or persists. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.
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