Zaditor
Zaditor is an FDA drug label for the active ingredient KETOTIFEN FUMARATE manufactured by Alcon Laboratories, Inc. administered by OPHTHALMIC. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231215.
Generic: KETOTIFEN FUMARATE
Manufacturer: Alcon Laboratories, Inc.
Product Type: HUMAN OTC DRUG
Route: OPHTHALMIC
Dosage Form:
NDC: 0065-4011
Application: ANDA077200
Effective: 20231215
Active Ingredients: Active ingredient Purpose Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%) Antihistamine
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
Contraindications
Not available.
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
Adverse Reactions
Not available.
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