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Ketotifen Fumarate by Advanced Vision Research (Subsidiary of Akorn, Inc.)

Medically reviewed on June 4, 2018

Dosage form: solution
Ingredients: Ketotifen Fumarate 0.35mg in 1mL
Labeler: Advanced Vision Research (Subsidiary of Akorn, Inc.)
NDC Code: 58790-008

Drug Facts

Active ingredient

Ketotifen (0.025%)

(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 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 Container Label:

Thera Tears logo NDC 58790-008-10

Ketotifen Fumarate

Ophthalmic Solution

ANTIHISTAMINE EYE DROPS

Sterile ALLERGY

EYE ITCH

0.34 FL OZ (10 mL) RELIEF

Principal Display Panel Text for Carton Label:

100% More Free*

*10 ml for the

price of

5 ml

Thera Tears logo

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops STERILE

ALLERGY

EYE ITCH

RELIEF

Up to

12

Hours

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

ADVANCED

VISION RESEARCH logo

0.34 FL OZ (10 mL) AN AKORN COMPANY

KETOTIFEN FUMARATE 
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58790-008
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ketotifen Fumarate (Ketotifen) Ketotifen Fumarate0.35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride 
Glycerin 
Water 
Hydrochloric Acid 
Sodium Hydroxide 
Packaging
#Item CodePackage Description
1NDC:58790-008-051 BOTTLE, DROPPER (1 BOTTLE) in 1 CARTON
15 mL in 1 BOTTLE, DROPPER
2NDC:58790-008-101 BOTTLE, DROPPER (1 BOTTLE) in 1 CARTON
210 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795803/15/2012
Labeler - Advanced Vision Research (Subsidiary of Akorn, Inc.) (969124536)
Establishment
NameAddressID/FEIOperations
Akorn, Inc603980319MANUFACTURE(58790-008), ANALYSIS(58790-008), STERILIZE(58790-008), PACK(58790-008), LABEL(58790-008)

 
Advanced Vision Research (Subsidiary of Akorn, Inc.)

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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