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Product NDC Code | 24208-537 | ||||||||||||||||||||
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Drug Name | Lumify redness reliever eye drops |
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Type | Brand | ||||||||||||||||||||
Pharm Class | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |
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Active Ingredients |
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Route | OPHTHALMIC | ||||||||||||||||||||
Dosage Form | SOLUTION/ DROPS | ||||||||||||||||||||
RxCUI drug identifier | 1999016, 1999021 |
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Application Number | NDA208144 | ||||||||||||||||||||
Labeler Name | Bausch & Lomb Incorporated | ||||||||||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Brimonidine tartrate (0.025%)
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 • adults and children 5 years of age and over: • instill 1 drop in the affected eye(s) every 6-8 hours • do not use more than 4 times daily • remove contact lenses before use • wait at least 10 minutes before re-inserting contact lenses after use • if using other ophthalmic products while using this product, wait at least 5 minutes between each product • to avoid contamination, do not touch tip of container to any surface • replace cap after each use • children under 5 years of age: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, boric acid, calcium chloride dihydrate, glycerin, potassium chloride, sodium borate decahydrate, sodium chloride, water for injection. Hydrochloric acid and/or sodium hydroxide may be used 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 • 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.LUMIFY Redness Reliever Eye Drops BRIMONIDINE TARTRATE BENZALKONIUM CHLORIDE BORIC ACID CALCIUM CHLORIDE GLYCERIN POTASSIUM CHLORIDE SODIUM BORATE SODIUM CHLORIDE WATER BRIMONIDINE TARTRATE BRIMONIDINE
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 - 7.5 mL Carton BAUSCH + LOMB NDC 24208-537-25 LARGE SIZE LUMIFY ® BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.025% REDNESS RELIEVER EYE DROPS • Works in 1 minute • Lasts up to 8 hours Sterile 0.25 FL OZ (7.5 mL) AB53708 3838702 carton
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.Other information • store at 15-25°C (59-77°F)
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Stop use and ask a doctor if • you experience eye pain, changes in vision, continued redness or irritation of the eye • condition worsens or persists for more than 3 days
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.
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? Call: 1-800-553-5340
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 Stop use and ask a doctor if • you experience eye pain, changes in vision, continued redness or irritation of the eye • condition worsens or persists for more than 3 days 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