KETOTIFEN FUMARATE- ketotifen fumarate solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Ketotifen Fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G)

Mevcut itibaren:

Advanced Vision Research (Subsidiary of Akorn, Inc.)

INN (International Adı):

Ketotifen Fumarate

Kompozisyon:

Ketotifen Fumarate 0.35 mg in 1 mL

Uygulama yolu:

OPHTHALMIC

Reçete türü:

OTC DRUG

Terapötik endikasyonlar:

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

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

KETOTIFEN FUMARATE- KETOTIFEN FUMARATE SOLUTION
ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)
----------
_DRUG FACTS_
ACTIVE INGREDIENT
Ketotifen (0.025%)
(equivalent to Ketotifen Fumarate 0.035%)
PURPOS E
Antihistamine
US ES
Temporary 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 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
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.
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° to 77° F) [see USP Controlled Room
Temperature].
INACTIVE INGREDIENTS
Benzalkonium Chloride 0.01%; Glycerin and Purified Water. May contain
Hydrochloric Acid and/or
Sodium Hydroxide (to adjust pH).
QUES TIONS ?
call toll-free 1-800-579-8327, weekdays, 7:00 AM-5:30 PM EST
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
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
Principal Display Panel Te