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| Product NDC Code | 0536-1432 | ||
|---|---|---|---|
| Drug Name | Brimonidine tartrate |
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| Type | Generic | ||
| 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 | ||
| Application Number | ANDA216361 | ||
| Labeler Name | Rugby Laboratories | ||
| 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(S) 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(S) • 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.BRIMONIDINE TARTRATE brimonidine tartrate BRIMONIDINE TARTRATE BRIMONIDINE BENZALKONIUM CHLORIDE BORIC ACID CALCIUM CHLORIDE GLYCERIN POTASSIUM CHLORIDE SODIUM BORATE SODIUM CHLORIDE WATER Carton
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 BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.025% REDNESS RELIEVER EYE DROPS •Works in 1 minute •Lasts up to 8 hours Sterile 0.08 FL OZ (2.5 mL)
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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFORMATION • store at 15° to 25°C (59° to 77°F)
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: 1-888-375-3784 Distributed by: RUGBY® LABORATORIES Indianapolis, IN 46268 (800) 616-2471 Made in India
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 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
Pregnancy or breast feeding
Pregnancy or Breast feedingPREGNANCY/BREASTFEEDING If 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
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