Ketotifen Fumarate KETOTIFEN FUMARATE PREFERRED PHARMACEUTICALS INC. FDA Approved Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
FunFoxMeds bottle
Substance Ketotifen Fumarate
Route
OPHTHALMIC
Applications
ANDA204059
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)
Inactive Ingredients
Inactive ingredients benzalkonium chloride 0.01% glycerol water for injection sodium hydroxide and/or hydrochloric acid.
Quantities
5 ml
Treats Conditions
Use Temporarily Relieves Itchy Eyes Due To Pollen Ragweed Grass Animal Hair And Dander

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
HBD503WORO
Packaging

Principal Display Panel - Bottle Carton NDC 68788-8715-5 Ketotifen Fumarate Opthalmic Solution 0.035% ANTIHISTAMINE EYE DROPS UP TO 12 HOURS Eye Itch Relief Works in Minutes Original Prescription Strength for ages 3 years and older 20 day supply 5 mL (0.17 FL OZ) Sterile Ketotifen Fumarate Ophthalmic Solution 0.035%

Package Descriptions
  • Principal Display Panel - Bottle Carton NDC 68788-8715-5 Ketotifen Fumarate Opthalmic Solution 0.035% ANTIHISTAMINE EYE DROPS UP TO 12 HOURS Eye Itch Relief Works in Minutes Original Prescription Strength for ages 3 years and older 20 day supply 5 mL (0.17 FL OZ) Sterile Ketotifen Fumarate Ophthalmic Solution 0.035%

Overview

Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Indications & Usage

Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Dosage & Administration

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.

Warnings & Precautions
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.
Purpose

Purpose Antihistamine

Do Not Use

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

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 & Ask a Doctor

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Questions

Questions? Call Product Information at 973-315-1818. Serious side effects associated with use of this product may be reported to this number. Code No.: GO/DRUGS/557 Manufactured For: Bayshore Pharmaceuticals LLC., Short Hills, NJ 07078 Made in India. Relabeled By: Preferred Pharmaceuticals Inc.


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