KETOTIFEN FUMARATE solution/ drops

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

ketotifen fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G)

Saatavilla:

Akorn

INN (Kansainvälinen yleisnimi):

ketotifen fumarate

Koostumus:

Ketotifen 0.35 mg in 1 mL

Antoreitti:

OPHTHALMIC

Prescription tyyppi:

OTC DRUG

Käyttöaiheet:

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

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

KETOTIFEN FUMARATE- KETOTIFEN FUMARATE SOLUTION/ DROPS
AKORN
----------
_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.
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° 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
Add and/or Sodium Hydroxide (to adjust pH).
QUESTIONS?
call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST
Principal Display Panel Text for Container Label:
NDC 17478-717-10
Ketotifen Fumarate
Ophthalmic Solution
ANTIHISTAMINE EYE DROPS
5 mL (0.17 FL OZ) Sterile
Principal Display Panel Text for Carton Label:
Now OTC! NDC 17478-060-12
Akorn Logo
Ketotifen
Fumarate
Ophthalmic
Solution
ANTIHISTAMINE EYE DROPS
UP TO 12 HOURS EYE ITCH RELIEF
Works in Minutes
Original Prescription Strength
FOR AGES 3 YEARS AND OLDER
30 DAY SUPPLY
5 mL (0.17 FL OZ) Sterile
KETOTIFEN FUMARATE
ketotifen fumarate solution/ drops
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:17478