Ketotifen Fumarate

Advanced Vision Research (Subsidiary of Akorn, Inc.)

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• Ketotifen Fumarate Uses
• Warnings
  • Do not use
  • When using this product
• Directions
• Ketotifen Fumarate Other information
• Inactive ingredients
• Questions?

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Ketotifen (0.025%)

(equivalent to Ketotifen Fumarate 0.035%)

Purpose

Antihistamine

Uses

Temporary 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 surfaces 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.

Directions

• Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 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°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature].

Inactive ingredients

Benzalkonium Chloride 0.01%; Glycerin and Purified Water. May contain Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH).

Questions?

call toll-free 1-800-579-8327, weekdays, 7:00 AM-5:30 PM EST

Principal Display Panel Text for Container Label:

Thera Tears logo NDC 58790-008-05
Ketotifen Fumarate
Ophthalmic Solution
ANTIHISTAMINE EYE DROPS
Sterile                EYE ITCH
5mL (0.17 FL OZ)      RELIEF