OTC Medication Information: Ketotifen Fumarate
KETOTIFEN FUMARATE- ketotifen fumarate solution/ drops
A-S Medication Solutions
Drug Facts
Active ingredient
Ketotifen (0.025%)
(equivalent to Ketotifen Fumarate 0.035%)
Purpose
Antihistamine
Use
Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
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.
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.
Other information
- Only for use in the eye.
- Store at 20° to 25°C (68° TO 77°F) [see USP Controlled Room Temperature].
Inactive ingredients
Benzalkonium Chloride 0.01%; Glycerin and Purified Water. May contain Hydrochloric Add and/or Sodium Hydroxide (to adjust pH).
Questions?
call toll-free 1-800-932-5676, weekdays, 7:00 AM — 5:30 PM CST
HOW SUPPLIED
Product: 50090-2900
NDC: 50090-2900-0 5 mL in a BOTTLE, DROPPER / 1 in a CARTON
Ketotifen Fumarate
Label Image KETOTIFEN FUMARATE ketotifen fumarate solution/ drops | |||||||||||||||||
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Labeler — A-S Medication Solutions (830016429) |
Establishment | |||
Name | Address | ID/FEI | Operations |
A-S Medication Solutions | 830016429 | RELABEL (50090-2900) |
Revised: 12/2023 A-S Medication Solutions
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.