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ZADITOR

Alcon Laboratories, Inc.
Alcon Laboratories, Inc.

ZADITOR®ANTIHISTAMINE EYE DROPS DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

OTC - ACTIVE INGREDIENT SECTION

Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%)

OTC - PURPOSE SECTION

Antihistamine

INDICATIONS & USAGE SECTION

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

  • 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 INGREDIENT SECTION

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 use of this product may be reported to this number.

PRINCIPAL DISPLAY PANEL

NDC 0065-0333-05
STERILE

ZADITOR®
ketotifen fumarate ophthalmic solution
ANTIHISTAMINE EYE DROPS

up to 12 hours
EYE ITCH RELIEF

● Works in Minutes
● Original Prescription Strength

for ages 3 years and older
30 day supply

5 mL (0.17 FL OZ)

Alcon®

ZADITOR

ketotifen fumarate SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0065-0333
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Ketotifen Fumarate Ketotifen .35 mg

Inactive Ingredients

Ingredient Name Strength
benzalkonium chloride
GLYCERIN
SODIUM HYDROXIDE
HYDROCHLORIC ACID
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 BOTTLE, DROPPER
2 NDC:0065-0333-05 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021066 2009-09-22


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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