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Zaditor Antihistamine Eye Drops

Dosage form: solution
Ingredients: KETOTIFEN FUMARATE .345mg in 1mL
Labeler: Novartis Pharmaceuticals Corporation
NDC Code: 0078-0476

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

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 between 4°-25°C (39°-77°F).

Inactive ingredients

benzalkonium chloride 0.01%, glycerol, sodium hydroxide and/or hydrochloric acid, and purified water

Questions?

call toll-free

1-866-393-6336, weekdays,

8:30 AM - 5:00 PM EST.

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

PRINCIPAL DISPLAY PANEL

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

ZADITOR

ketotifen fumarate ophthalmic solution

Antihistamine Eye Drops

Original Prescription Strength

Up to 12 Hour Itch Relief

30 Day Supply

Works in Minutes

For Ages 3 Years and Older

Do not use if seal on bottle is missing or broken.

ZADITOR  ANTIHISTAMINE EYE DROPS
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0078-0476
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (KETOTIFEN) KETOTIFEN FUMARATE.345 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
GLYCERIN 
SODIUM HYDROXIDE 
HYDROCHLORIC ACID 
WATER 
Packaging
#Item CodePackage Description
1NDC:0078-0476-412 BOTTLE, DROPPER (BOTTLE) in 1 CARTON
15 mL in 1 BOTTLE, DROPPER
2NDC:0078-0476-611 BOTTLE, DROPPER (BOTTLE) in 1 CARTON
25 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02106609/22/2009
Labeler - Novartis Pharmaceuticals Corporation (002147023)

Revised: 09/2009
Document Id: 8a8ae065-07da-4e38-b9d8-9a6937f94f58
Set id: 8a8ae065-07da-4e38-b9d8-9a6937f94f58
Version: 1
Effective Time: 20090922
 
Novartis Pharmaceuticals Corporation

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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