Allergy Eye Drops description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

Allergy Eye Drops

Cardinal Health
Akorn, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Uses

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Warnings

Do not use

  • if solution changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
  • to treat contact lens related irritation

When using this product

  • do not touch tip of container to any surface to avoid contamination
  • remove contact lenses before use
  • wait at least 10 minutes before reinserting contact lenses after use
  • replace cap after each use

Stop use and ask a doctor if you experience any of the following:

  • eye pain
  • changes in vision
  • redness of the eye
  • itching worsens or lasts for more than 72 hours

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 3 years of age and older:
    Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.
  • Children under 3 years of age:
    Consult a doctor.

Other information

  • only for use in the eye
  • store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Inactive ingredients

benzalkonium chloride 0.01%, glycerin, purified water.

May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions or comments?

1-800-932-5676

Principal Display Panel Text for Container Label:

NDC 49781-078-71

LEADER Logo®

ORIGINAL PRESCRIPTION STRENGTH

Allergy Eye Drops

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

Sterile

0.17 FL OZ (5 mL)

Principal Display Panel Text for Carton Label:

NDC 49781-078-71

LEADER Logo®

Compare to

Zyrtec®

Itchy Eye Drops

active ingredient*

ORIGINAL

PRESCRIPTION

STRENGTH

Allergy

Eye Drops

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

Up to 12 Hours

Allergy Itchy Eye Relief

  • WORKS IN MINUTES
  • For Ages 3 Years & Older
  • 30 Day Supply

Sterile

SATISFACTION

GUARANTEED Logo

0.17 FL OZ (5 mL)

Allergy Eye Drops

Ketotifen Fumarate SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49781-078
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Ketotifen Fumarate Ketotifen 0.35 mg

Inactive Ingredients

Ingredient Name Strength
benzalkonium chloride
GLYCERIN
water
HYDROCHLORIC ACID
SODIUM HYDROXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 BOTTLE, DROPPER
2 NDC:49781-078-71 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077958 2014-01-13


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.