Drugplain

Zaditor .25 mg/mL

ketotifen fumarate · SOLUTION · Alcon Laboratories, Inc.

1 Recall on Record
Plain English

Zaditor is a solution containing ketotifen fumarate at .25 mg/mL, taken ophthalmic. Manufactured by Alcon Laboratories, Inc..

Key Facts

Brand Name
Zaditor
Generic Name
ketotifen fumarate
NDC Code (Product)
0065-4011
Manufacturer
Alcon Laboratories, Inc.
Strength
.25 mg/mL
Dosage Form
SOLUTION
Route
OPHTHALMIC
Marketing Status
Application #
ANDA077200
Marketing Start
01/08/2013

Recall History

1 Recall on Record
Class II06/29/2022

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations: products were stored outside the drug label specifications.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

treatment failure2,490 reports
drug ineffective654 reports
pruritus185 reports
eye irritation170 reports
fatigue162 reports
headache155 reports
hypersensitivity154 reports
nausea153 reports
dyspnoea147 reports
diarrhoea142 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 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

Frequently Asked Questions

What is Zaditor used for?

Zaditor contains ketotifen fumarate. It is a solution taken ophthalmic. Consult your doctor for specific uses.

Is Zaditor a controlled substance?

Zaditor is not classified as a controlled substance by the DEA.

What is the generic name for Zaditor?

The generic name for Zaditor is ketotifen fumarate. There are 11 other brand versions of ketotifen fumarate.

What is the NDC code for Zaditor .25 mg/mL?

The NDC (National Drug Code) for Zaditor .25 mg/mL is 0065-4011, listed by Alcon Laboratories, Inc..