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Ketotifen Fumarate by CVS Pharmacy

Dosage form: solution/ drops
Ingredients: ketotifen fumarate 0.35mg in 1mL
Labeler: CVS Pharmacy
NDC Code: 59779-627

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

Inactive ingredients

Benzalkonium Chloride 0.01%, Glycerin, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

Questions or comments?

1-800-932-5676

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

Principal Display Panel Text for Container Label:

CVS Health Logo

NDC 59779-627-01

Eye Itch Relief

Antihistamine

eye drops

KETOTIFEN FUMARATE

OPHTHALMIC

SOLUTION 0.035% STERILE

0.17 FL OZ (5 mL)

Principal Display Panel Text for Carton Label:

CVS Health Logo Compare to the active

ingredient in Zaditor®*

NDC 59779-627-01

Original Prescription Strength

Eye Itch

Relief

KETOTIFEN FUMARATE

OPHTHALMIC SOLUTION 0.035%

Antihistamine eye drops

• Works in minutes

• 30 day supply

• For ages 3 years and older

GET UP TO

12

HOUR

RELIEF

Actual Product

Size on Side Panel

STERILE

5 mL (0.17 FL OZ)

KETOTIFEN FUMARATE 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-627
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:59779-627-011 BOTTLE, DROPPER in 1 CARTON
15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795811/08/2013
Labeler - CVS Pharmacy (062312574)
Registrant - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIOperations
Akorn, Inc603980319MANUFACTURE(59779-627), ANALYSIS(59779-627), STERILIZE(59779-627), PACK(59779-627), LABEL(59779-627)
Establishment
NameAddressID/FEIOperations
Akorn, AG482198285MANUFACTURE(59779-627)
Establishment
NameAddressID/FEIOperations
Hi-Tech Pharmacal Co. Inc.101196749LABEL(59779-627), PACK(59779-627)

 
CVS Pharmacy

← See all Ketotifen Fumarate brands

Medically reviewed on Nov 19, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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