Home > Drugs A-Z > Ketotifen Fumarate

Ketotifen Fumarate (CVS Pharmacy)

Available Formats

Dosage Form Package Information Links
SOLUTION/ DROPS 1 BOTTLE, DROPPER in 1 CARTON (59779-330-01) > 10 mL in 1 BOTTLE, DROPPER Label Information

Complete Ketotifen Fumarate Information

  • SPL UNCLASSIFIED SECTION

    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. (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, purified water. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).


  • QUESTIONS

    Figure
Questions or comments?

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    CVS Healthâ„¢ Logo NDC 59779-330-01

    Allergy Eye Drops

    KETOTIFEN FUMARATE

    OPHTHALMIC SOLUTION

    ANTIHISTAMINE EYE DROPS

    STERILE

    10 mL (0.34 FL OZ)

    Principal Display Panel Text for Container 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

    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

    STERILE

    10 mL (0.34 FL OZ)

    Principal Display Panel Text for Carton Label

  • INGREDIENTS AND APPEARANCE
    KETOTIFEN FUMARATE 
    ketotifen fumarate solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-330
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ketotifen fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen 0.35 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    benzalkonium chloride (UNII: F5UM2KM3W7)  
    glycerin (UNII: PDC6A3C0OX)  
    water (UNII: 059QF0KO0R)  
    hydrochloric acid (UNII: QTT17582CB)  
    sodium hydroxide (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-330-01 1 in 1 CARTON
    1 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077958 02/21/2013
    Labeler - CVS Pharmacy (062312574)
    Registrant - Akorn, Inc. (062649876)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc 603980319 MANUFACTURE(59779-330) , ANALYSIS(59779-330) , STERILIZE(59779-330) , PACK(59779-330) , LABEL(59779-330)