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  5. Label Information: Brimonidine Tartrate

FDA Label for Brimonidine Tartrate

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. DO NOT USE
    6. STOP USE AND ASK DOCTOR IF
    7. PREGNANCY/BREASTFEEDING
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PRINCIPAL DISPLAY PANEL

Brimonidine Tartrate Product Label

The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient(S)



Brimonidine tartrate (0.025%)


Purpose



Redness reliever


Use(S)



• relieves redness of the eye due to minor eye irritations


Warnings



For external use only


Do Not Use



• if solution changes color or becomes cloudy


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/Breastfeeding



If pregnant or breast-feeding, ask a health professional before use.


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).


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

Other Information



• store at 15° to 25°C (59° to 77°F)


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.


Questions Or Comments?



Call: 1-888-375-3784

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

(800) 616-2471

Made in India


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) 

  


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