KETOTIFEN FUMARATE- ketotifen fumarate solution 
Advanced Vision Research (Subsidiary of Akorn, Inc.)

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Drug Facts

Active ingredient

Ketotifen (0.25%

(equivalent to Ketotifen Fumarate 0.035%)

Purpose

Antihistamine

Uses

Temporary 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 surfaces 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°C 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 Acid and/or Sodium Hydroxide (to adjust pH).

Questions?

call toll-free 1-800-579-8327, weekdays, 7:00 AM-5:30 PM EST

Principal Display Panel Text for Container Label:

Thera Tears logo NDC 58790-008-05
Ketotifen Fumarate
Ophthalmic Solution
ANTIHISTAMINE EYE DROPS
Sterile                EYE ITCH
5mL (0.17 FL OZ)      RELIEF

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

Thera Tears logo
Ketotifen Fumarate
Ophthalmic Solution
Antihistamine Eye Drops STERILE
EYE ITCH
RELIEF
Up to
12
Hours

  • Works in Minutes
  • Original Prescription
    Strength
  • For Ages 3 Years and Older
  • 30 Day Supply

                      ADVANCED
                      VISION RESEARCH logo
0.17 FL OZ (5 mL)     AN AKORN COMPANY

Principal Display Panel Text for Carton Label
KETOTIFEN FUMARATE 
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58790-008
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ketotifen Fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen0.35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Hydrochloric Acid (UNII: QTT17582CB)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58790-008-051 in 1 CARTON03/15/201201/31/2017
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795803/15/201201/31/2017
Labeler - Advanced Vision Research (Subsidiary of Akorn, Inc.) (117696736)

Revised: 10/2020
Document Id: 6a0e161b-60dd-4404-a5f5-99e0f246d5a5
Set id: 39856d6d-31ed-4184-9831-b40efdf4dcf4
Version: 3
Effective Time: 20201023
 
Advanced Vision Research (Subsidiary of Akorn, Inc.)