Ketotifen Fumarate

CVS Pharmacy
Akorn, Inc.

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• Ketotifen Fumarate Uses
• Warnings
  • Do not use
  • When using this product
  • Keep out of reach of children.
• Directions
• Questions or comments?
• Ketotifen Fumarate Other information
• Inactive ingredients

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 more than 72 hours

Keep out of reach of children.

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

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.

Questions or comments?

1-800-932-5676

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.

Principal Display Panel Text for Container Label:

CVS

pharmacy^®

NDC 59779-627-01

EYE ITCH

RELIEF

KETOTIFEN FUMARATE

OPHTHALMIC SOLUTION

ANTIHISTAMINE EYE DROPS

5 mL (0.17 FL OZ) Sterile