Ketotifen Fumarate

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ketotifen (0.025%)

(equivalent to Ketotifen Fumarate 0.035%)

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

• 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

OTC - WHEN USING SECTION

• do not touch tip of container to any surfaces to avoid contamination
• remove contact lenses before use
• wait at least 10 minutes before reinserting contact lenses after use
• replace cap after each use

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

• Only for use in the eye.
• Store at 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.01%; Glycerin and Purified Water. May contain Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH).

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-800-579-8327, weekdays, 7:00 AM-5:30 PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

Thera Tears logo NDC 58790-008-05
Ketotifen Fumarate
Ophthalmic Solution
ANTIHISTAMINE EYE DROPS
Sterile                EYE ITCH
5mL (0.17 FL OZ)      RELIEF

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

Thera Tears logo
Ketotifen Fumarate
Ophthalmic Solution
Antihistamine Eye Drops STERILE
EYE ITCH
RELIEF
Up to
12
Hours

• Works in Minutes
• Original Prescription
  Strength
• For Ages 3 Years and Older
• 30 Day Supply

                      ADVANCED
                      VISION RESEARCH logo
0.17 FL OZ (5 mL)     AN AKORN COMPANY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

Thera Tears logo NDC 58790-008-10

Ketotifen Fumarate

Ophthalmic Solution

ANTIHISTAMINE EYE DROPS

Sterile ALLERGY

EYE ITCH

0.34 FL OZ (10 mL) RELIEF

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

100% More Free *

*10 ml for the

price of

5 ml

Thera Tears logo

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops STERILE

ALLERGY

EYE ITCH

RELIEF

Up to

12

Hours

• Works in Minutes
• Original Prescription
  Strength
• For Ages 3 Years and Older
• 60 Day Supply

ADVANCED

VISION RESEARCH logo

0.34 FL OZ (10 mL) AN AKORN COMPANY

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

• Ketotifen Fumarate
• Ketotifen
• Benzalkonium Chloride
• Glycerin
• Water
• Hydrochloric Acid
• Sodium Hydroxide

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 421 matching rows.

Orange Book application contexts#

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Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.