Ketotifen Fumarate description, usages, side effects, indications, overdosage, supplying and lots more!

Ketotifen Fumarate

Walgreens
Akorn, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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. (1 -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°C to 25°C (68°F 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?

1-800-579-8327

Principal Display Panel Text for Container Label:

Well at

Walgreens NDC 0363-9060-00

STERILE ● ORIGINAL

PRESCRIPTION STRENGTH

Eye Itch Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops 0.34 FL OZ (10 mL)

Principal Display Panel Text for Carton Label:

Well at

Walgreens NDC 0363-9060-00

WALGREENS PHARMACIST RECOMMENDED≠

STERILE ● ORIGINAL

PRESCRIPTION STRENGTH

Eye Itch

Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

  • Works in minutes
  • For ages 3 years & older
  • 60-day supply

12

HOUR

0.34 FL OZ (10 mL)

Ketotifen Fumarate

Ketotifen Fumarate SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0363-9060
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Ketotifen Fumarate Ketotifen 0.35 mg

Inactive Ingredients

Ingredient Name Strength
benzalkonium chloride
GLYCERIN
water
HYDROCHLORIC ACID
SODIUM HYDROXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BOTTLE, DROPPER
2 NDC:0363-9060-00 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077958 2013-01-25


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