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| Product NDC Code | 0498-0161 | ||||
|---|---|---|---|---|---|
| Drug Name | Eye drops |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | SOLUTION/ DROPS | ||||
| RxCUI drug identifier | 1052943 | ||||
| Application Number | M018 | ||||
| Labeler Name | Honeywell Safety Products USA, 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 Tetrahydrozoline HCl 0.05%
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) up to four times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium 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 relieves redness of the eye due to minor eye irritations
Purpose
Information about the drug product’s indications for use.Purpose Redness reliever
Spl product data elements
Usually a list of ingredients in a drug product.Eye Drops Tetrahydrozoline hydrochloride BENZALKONIUM CHLORIDE BORIC ACID EDETATE DISODIUM WATER SODIUM BORATE SODIUM CHLORIDE TETRAHYDROZOLINE HYDROCHLORIDE TETRAHYDROZOLINE
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.Eye Drops
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
Tamper evident. Do not use this product if imprinted neckband is missing or broken. RETAIN THIS CARTON FOR FUTURE REFERENCE Distributed by North by Honeywell 900 Douglas Pike Smithfield, RI 02917 Questions? Call 800-430-5490
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have narrow angle glaucoma
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 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 experience eye pain, changes in vision, continued redness or 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 pupils may become enlarged temporarily overuse may produce increased redness of the eye remove contact lenses before using to avoid contamination, do not touch tip of container to any surface replace cap after using
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information S tore at 15° to 30°C (59° to 86°F)
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 Ask a doctor before use if you have narrow angle glaucoma When using this product pupils may become enlarged temporarily overuse may produce increased redness of the eye remove contact lenses before using to avoid contamination, do not touch tip of container to any surface replace cap after using Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye the condition worsens or persists for more than 72 hours If pregnant or breast-feeding, ask a health professional before use. 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