Ketotifen Fumarate by AMERISOURCEBERGEN DRUG CORPORATION Drug Facts

Ketotifen Fumarate by

Drug Labeling and Warnings

Ketotifen Fumarate by is a Otc medication manufactured, distributed, or labeled by AMERISOURCEBERGEN DRUG CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KETOTIFEN FUMARATE- ketotifen fumarate solution 
AMERISOURCEBERGEN DRUG CORPORATION

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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

For external use only

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.

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°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Inactive ingredients

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

Questions or comments?

Call toll-free 1-800-706-5575

Weekdays 8:30 AM - 5:00 PM Eastern Standard Time

Principal Display Panel - Bottle Label

Good Neighbor Pharmacy

NDC: 46122-304-01

Eye Itch Relief

Ketotifen Fumarate Opthalmic Solution 0.025% 5 ml bottle

bottle-label

Principal Display Panel - Bottle Carton

Good Neighbor Pharmacy

NDC: 46122-304-01

Eye Itch Relief

Ketotifen Fumarate Opthalmic Solution 0.025% 5 ml bottle

Carton-label

KETOTIFEN FUMARATE 
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 46122-304
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen 0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 46122-304-011 in 1 CARTON10/10/201912/10/2019
15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07735410/10/201912/10/2019
Labeler - AMERISOURCEBERGEN DRUG CORPORATION (007914906)

Revised: 12/2019
Document Id: 74bae49d-cd1e-ed28-951f-b0f9f756c049
Set id: eff4c27e-f633-7255-7741-ad4eaf542898
Version: 2
Effective Time: 20191210
 
AMERISOURCEBERGEN DRUG CORPORATION