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Eye Drops

Rugby Laboratories Inc.
Bausch & Lomb Incorporated

Eye Drops Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Tetrahydrozoline HCl 0.05%

Purpose

Redness Reliever

Eye Drops Uses

  • relieves redness of the eye due to minor eye irritations

Warnings

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  

  • do not touch tip of container to any surface to avoid contamination
  • overuse may produce increased redness of the eye
  • pupils may become enlarged temporarily

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 72 hours

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • instill 1 to 2 drops in the affected eye(s) up to four times daily

Eye Drops Other information

  • store at 15° - 30°C (59° - 86°F)
  • keep tightly closed
  • replace cap after use

Inactive ingredients

boric acid, edetate disodium, sodium borate, sodium chloride, purified water.

Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

PRESERVATIVE: benzalkonium chloride 0.01%

Questions or comments?

Call 1-800-645-2158

9 am - 5 pm ET, Monday-Friday.

Serious side effects associated with use of this product may be reported to this number.

Package/Label Principal Display Panel

Eye Drops

NDC 0536-0940-94

Rugby®

COMPARED TO ACTIVE INGREDIENT IN VISINE® ORIGINAL*

Eye Drops

Tetrahydrozoline HCl 0.05%
Ophthalmic Solution, USP
Sterile

Redness Reliever

1/2 fl oz (15 mL)

Rugby®

Eye Drops

Tetrahydrozoline HCl SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0536-0940
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
TETRAHYDROZOLINE HYDROCHLORIDE TETRAHYDROZOLINE 0.5 mg

Inactive Ingredients

Ingredient Name Strength
BORIC ACID
EDETATE DISODIUM
SODIUM BORATE
SODIUM CHLORIDE
water
benzalkonium chloride

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-0940-94 15 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part349 2011-10-07


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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