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

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)

Revised: 06/2012
 
Advanced Vision Research (Subsidiary of Akorn, Inc.)

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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