Ketotifen Fumarate
Ketotifen Fumarate is an FDA drug label for the active ingredient KETOTIFEN FUMARATE manufactured by A-S Medication Solutions 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 20230511.
Generic: KETOTIFEN FUMARATE
Manufacturer: A-S Medication Solutions
Product Type: HUMAN OTC DRUG
Route: OPHTHALMIC
Dosage Form:
NDC: 50090-6472
Application: NDA021996
Effective: 20230511
Active Ingredients: Active ingredient Ketotifen 0.025% (equivalent to ketotifen fumerate 0.035%)
Indications & Usage
Uses For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
Dosage & Administration
Directions Adults and children 3 years 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 you are sensitive to any ingredient in this product ▪ if solution changes color or becomes cloudy ▪ to treat contact lens related irritation When using this product ▪ remove contact lenses before use ▪ wait at least 10 minutes before re-inserting contact lenses after use ▪ do not touch tip of container to any surface to avoid contamination ▪ replace cap after each use Stop use and ask doctor if you experience any of the following: ▪ eye pain ▪ changes in vision ▪ redness of the eyes ▪ itching that worsens or lasts more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Adverse Reactions
Not available.
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