Ketotifen Fumarate

CVS Pharmacy
Akorn, Inc.

FULL PRESCRIBING INFORMATION: CONTENTS*

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

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Use

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 8-12 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°-25°C (68°-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?

1-800-579-8327

Principal Display Panel Text for Container Label:

CVS

pharmacy^®

NDC 59779-330-01

ALLERGY

EYE DROPS

KETOTIFEN FUMARATE

OPHTHALMIC SOLUTION

ANTIHISTAMINE

EYE DROPS

10 mL (0.34 FL OZ) STERILE