KETOTIFEN FUMARATE- ketotifen fumarate solution/ drops 
CVS Pharmacy

----------

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (I -800-222-1222)

Directions

  • Adults and children 3 years of age and older:
    Put 1 drop in the affected eye(s) twice daily, every 8-12 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°-25°C (68°-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).

Figure Questions or comments?

1-800-579-8327

Principal Display Panel Text for Container Label:

CVS

pharmacy®

NDC 59779-330-01

ALLERGY

EYE DROPS

KETOTIFEN FUMARATE

OPHTHALMIC SOLUTION

ANTIHISTAMINE

EYE DROPS

10 mL (0.34 FL OZ) STERILE

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

CVS

pharmacy®

NDC 59779-330-01

Compare to the

active ingredient

in Alaway®*

Contains the drug

Ketotifen Fumarate

ALLERGY

EYE DROPS

KETOTIFEN FUMARATE

OPHTHALMIC SOLUTION

ANTIHISTAMINE

EYE DROPS

Works in minutes

● Original prescription strength

● For ages 3 years & older

● Relief for itchy eyes

● 60-day supply

up to

12

HOURS

10 mL ITCH RELIEF

(0.34 FL OZ)

STERILE

Principal Display Panel Text for Carton Label
KETOTIFEN FUMARATE 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-330
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 DescriptionMarketing Start DateMarketing End Date
1NDC:59779-330-011 in 1 CARTON
110 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795802/21/2013
Labeler - CVS Pharmacy (062312574)
Registrant - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc603980319MANUFACTURE(59779-330), ANALYSIS(59779-330), STERILIZE(59779-330), PACK(59779-330), LABEL(59779-330)

Revised: 2/2013
Document Id: 2cd7f1e6-d3d7-4ed2-b8e1-55be52c19b31
Set id: 9d4d00c3-1bb3-46a9-9ad3-7ec26c500770
Version: 1
Effective Time: 20130221
 
CVS Pharmacy