Allergy Relief Eye Drops by Kinray Inc. / Akorn, Inc. / Akorn, Inc

Allergy Relief Eye Drops by

Drug Labeling and Warnings

Allergy Relief Eye Drops by is a Otc medication manufactured, distributed, or labeled by Kinray Inc., Akorn, Inc. , Akorn, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALLERGY RELIEF EYE DROPS- ketotifen fumarate solution/ drops 
Kinray Inc.

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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 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, 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:

Preferred plus Pharmacy Logo®

NDC: 61715-097-05

ALLERGY
RELIEF EYE

DROPS

Ketotifen Fumarate

Ophthalmic Solution

ANTIHISTAMINE EYE DROPS

5 mL (0.17 FL OZ) STERILE

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

NDC: 61715-097-05

Preferred plus Pharmacy Logo® *Compare to the active

ingredient in Zyrtec®

ALLERGY

RELIEF EYE

DROPS

Ketotifen Fumarate

Ophthalmic Solution

ANTIHISTAMINE EYE DROPS

  • Works in minutes
  • Original prescription strength
  • For ages 3 years & older
  • 30-day supply

UP TO

12

HOURS

ITCH RELIEF

SATISFACTION GUARANTEED Logo

5 mL (0.17 FL OZ) STERILE

Principal Display Panel Text for Carton Label
ALLERGY RELIEF EYE DROPS 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61715-097
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ketotifen Fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen0.35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Hydrochloric Acid (UNII: QTT17582CB)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61715-097-051 in 1 CARTON03/18/201409/01/2016
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795803/18/201409/01/2016
Labeler - Kinray Inc. (012574513)

Revised: 3/2014
Document Id: 44b9fb8d-ed52-4fa4-8717-c1a22fd1e26d
Set id: 541d3409-5c40-46c9-8062-26cb57a6b7fe
Version: 2
Effective Time: 20140318
 
Kinray Inc.