Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
ketotifen fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G)
Akorn
ketotifen fumarate
Ketotifen 0.35 mg in 1 mL
OPHTHALMIC
OTC DRUG
Antihistamine Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Abbreviated New Drug Application
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 Przeczytaj cały dokument