Ketotifen Fumarate Ophthalmic Solution .25 mg/mL
Ketotifen Fumarate · SOLUTION/ DROPS · Sentiss Pharmaceuticals LLC
Ketotifen Fumarate Ophthalmic Solution is a solution/ drops containing ketotifen fumarate at .25 mg/mL, taken ophthalmic. Manufactured by Sentiss Pharmaceuticals LLC.
Key Facts
- Brand Name
- Ketotifen Fumarate Ophthalmic Solution
- Generic Name
- Ketotifen Fumarate
- NDC Code (Product)
70244-041- Manufacturer
- Sentiss Pharmaceuticals LLC
- Strength
- .25 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA077958
- Marketing Start
- 04/15/2026
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
Akorn, Inc.
CGMP Deviations
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Dosage & Administration
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.
Warnings
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.
Frequently Asked Questions
What is Ketotifen Fumarate Ophthalmic Solution used for?
Ketotifen Fumarate Ophthalmic Solution contains Ketotifen Fumarate. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Ketotifen Fumarate Ophthalmic Solution a controlled substance?
Ketotifen Fumarate Ophthalmic Solution is not classified as a controlled substance by the DEA.
What is the generic name for Ketotifen Fumarate Ophthalmic Solution?
The generic name for Ketotifen Fumarate Ophthalmic Solution is Ketotifen Fumarate. There are 11 other brand versions of Ketotifen Fumarate.
What is the NDC code for Ketotifen Fumarate Ophthalmic Solution .25 mg/mL?
The NDC (National Drug Code) for Ketotifen Fumarate Ophthalmic Solution .25 mg/mL is 70244-041, listed by Sentiss Pharmaceuticals LLC.
Other Ketotifen Fumarate Ophthalmic Solution Dosages
Other Ketotifen Brands
See all →- Eye Itch Relief.25 mg/mL69842-275
- Eye Itch Relief.35 mg/mL70000-0124
- KETOTIFEN FUMARATE.25 mg/mL76385-106
- Zaditor.25 mg/mL0065-4011
- Eye Itch Releif.25 mg/mL11822-5533
- Eye Itch Relief.25 mg/mL21130-601
- Alaway.25 mg/mL24208-601
- Eye Itch Relief.25 mg/mL36800-097
- Eye Itch Relief.25 mg/mL50804-601
- Eye Itch Relief.25 mg/mL70000-0522
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)