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Eye Itch Relief by Amerisource Bergen

Medically reviewed on December 5, 2017

Dosage form: solution/ drops
Ingredients: ketotifen fumarate 0.35mg in 1mL
Labeler: Amerisource Bergen
NDC Code: 46122-163

Drug Facts

Active ingredient

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Uses

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions
  • Adults and children 3 years of age and older:

    Put 1 drop in the affected eye(s) twice daily, every 8 to 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° to 25°C (68° to 77°F)

[see USP Controlled Room Temperature].

Inactive ingredients

benzalkonium chloride 0.01%, glycerin, purified water.

May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions or comments?

1-800-932-5676

Principal Display Panel Text for Container Label:

NDC 46122-163-64

GOOD NEIGHBOR PHARMACY Logo® Sterile

Eye Itch Relief

ketotifen fumarate

ophthalmic solution

Antihistamine Eye Drops

0.17 fl oz (5 mL)

Principal Display Panel Text for Carton Label:

NDC 46122-163-64

Compare to

Zaditor®

active ingredient*

GOOD NEIGHBOR PHARMACY Logo®

► 30 DAY SUPPLY

Eye Itch

Relief

ketotifen fumarate

ophthalmic solution

Antihistamine Eye Drops

Up to 12 hours

Works in minutes

Original Prescription Strength

For ages 3 years and older

Sterile

0.17 fl oz

(5 mL)

EYE ITCH RELIEF 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-163
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ketotifen fumarate (ketotifen) ketotifen0.35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
benzalkonium chloride 
glycerin 
water 
hydrochloric acid 
sodium hydroxide 
Packaging
#Item CodePackage Description
1NDC:46122-163-641 BOTTLE, DROPPER in 1 CARTON
15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795812/06/2013
Labeler - Amerisource Bergen (007914906)
Registrant - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIOperations
Akorn, Inc603980319MANUFACTURE(46122-163), ANALYSIS(46122-163), STERILIZE(46122-163), PACK(46122-163), LABEL(46122-163)

 
Amerisource Bergen

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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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