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Generic: ketotifen fumarate is used for the treatment of Conjunctivitis, Allergic Rhinitis, Allergic, Perennial

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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


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

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

OTC - STOP USE SECTION


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. (1-800-222-1222)

Directions

  • Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 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, water for injection. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Otc - Questions Section


Questions or comments?

1-800-579-8327

Serious side effects associated with use of this product may be reported to this number

Package Label.principal Display Panel


Principal Display Panel Text for Container Label:

CVS Healthâ„¢ Logo NDC 59779-330-01

Allergy Eye Drops

KETOTIFEN FUMARATE

OPHTHALMIC SOLUTION 0.035%

ANTIHISTAMINE EYE DROPS

STERILE

10 mL (0.34 FL OZ)

Package Label.principal Display Panel


Principal Display Panel Text for Carton Label:

CVS Healthâ„¢ Logo Compare to the active

ingredient in Alaway®*

NDC 59779-330-01

Contains the drug

Ketotifen Fumarate

Allergy

Eye Drops

KETOTIFEN FUMARATE

OPHTHALMIC SOLUTION 0.035%

ANTIHISTAMINE EYE DROPS

Works in minutes

• Original prescription strength

• For ages 3 years & older

• Relief for itchy eyes

• 60-day supply

GET UP TO

12

HOURS

ITCH RELIEF

Actual Product

Size on Side Panel

STERILE

10 mL (0.34 FL OZ)

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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