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Goniovisc

HUB Pharmaceuticals, LLC

GONIOVISC Eye Lubricant Hypromellose Ophthalmic Solution, USP 2.5%, Drops (Sterile)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENTS:

Active Ingredients             Purpose

Hypromellose 25 mg (2.5%)......Lubricant

USES:

  • For use as a lubricant to prevent further irritation or to relieve dryness of the eye.
  • For use in the eyes only.

For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

WARNINGS:

  • For external use only.
  • Do not use if sealed bottle tip is broken or punctured.
  • If solution changes color or becomes cloudy, do not use.
  • To avoid contamination, do not touch tip of container to any surface.

  • Replace cap after using.

If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.

ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Instill 1 or 2 drops in the affected eye(s) as needed.

OTHER INFORMATION:

  • Store at room temperature 15°-30°C (59°-86°F).
  • Do not freeze.
  • Keep box for complete information.

INACTIVE INGREDIENTS:

Inactive Ingredients:

  • Boric Acid
  • Edetate Disodium
  • Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (6.0-7.8)
  • Sodium Borate

  • Water for Injection

Preservative:

  • Benzalkonium Chloride Solution NF 0.02% v/v

1-800-Eye-Drop (393-3767)

PACKAGE LABELS:

Goniovisc


Image 1: Label for Bottle

Goniovisc


Image 2: Label for Box

Goniovisc

Hypromellose 2910 (4000 MPA.S) SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:17238-610
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HYPROMELLOSE 2910 (4000 MPA.S) 25 mg

Inactive Ingredients

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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BOTTLE, DROPPER
2 NDC:17238-610-15 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part349 2011-11-10


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Be sure to consult your doctor before taking any medication!
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