Alaway
Alaway is an FDA drug label for the active ingredient KETOTIFEN FUMARATE manufactured by Bausch & Lomb Incorporated 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 20220501.
Generic: KETOTIFEN FUMARATE
Manufacturer: Bausch & Lomb Incorporated
Product Type: HUMAN OTC DRUG
Route: OPHTHALMIC
Dosage Form:
NDC: 24208-601
Application: NDA021996
Effective: 20220501
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 • if using other ophthalmic products while using this product, wait at least 5 minutes between each product • 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 a doctor if you experience any of the following: • eye pain • changes in vision • redness of the eyes • itching that 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.
Adverse Reactions
Not available.
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