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Ketotifen Fumarate

Dosage form
SOLUTION
Labeler
Preferred Pharmaceuticals Inc.
Label updated
2026-05-15
Retrieved
2026-09-07
Active ingredients
See original label
View original label and images on DailyMed ↗
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

For external use only

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.

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°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].
Inactive ingredients

benzalkonium chloride 0.01%, glycerol, water for injection, sodium hydroxide and/or hydrochloric acid.

Questions?

Call Product Information at 973-315-1818. Serious side effects associated with use of this product may be reported to this number.

Code No.: GO/DRUGS/557

Manufactured For:
Bayshore Pharmaceuticals
LLC., Short Hills, NJ 07078
Made in India.

Relabeled By: Preferred Pharmaceuticals Inc.

Principal Display Panel - Bottle Carton

NDC 68788-8715-5

Ketotifen Fumarate Opthalmic Solution 0.035%

ANTIHISTAMINE EYE DROPS

UP TO 12 HOURS

Eye Itch Relief

Works in Minutes

Original Prescription Strength

for ages 3 years and older

20 day supply

5 mL (0.17 FL OZ)

Sterile

[Image in the official label — see DailyMed source]

DailyMed Set ID: 5196ec5b-42d9-40db-a77a-c00360b8cee6 · Version 3
NDC: 68788-8715