Alaway

Dosage form: solution/ drops
Ingredients: KETOTIFEN FUMARATE 0.25mg in 1mL
Labeler: Bausch & Lomb Incorporated
NDC Code: 24208-601

Drug Facts

Active ingredient

Ketotifen 0.025%
(equivalent to ketotifen fumerate 0.035%)

Purpose

Antihistamine

Uses

For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Warnings

Do not use

if you are sensitive to any ingredient in this product
if solution changes color or becomes cloudy
to treat contact lens related irritation

When using this product
remove contact lenses before use
wait at least 10 minutes before re-inserting contact lenses after use
do not touch tip of container to any surface to avoid contamination
replace cap after each use

Stop use and ask doctor if you experience any of the following:
eye pain
changes in vision
redness of the eyes
itching that worsens or lasts 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 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

Store at 4-25°C (39-77°F)

Inactive ingredients

benzalkonium chloride, 0.01%, glycerin, sodium hydroxide and/or hydrochloric acid and water for injection.

Questions or Comments?

Toll Free Product Information Call: 1-800-553-5340

Package/Label Principal Display Panel

NDC 24208-601-10

Bausch + Lomb

Alaway

KETOTIFEN FUMARATE OPHTHALMIC SOLUTION

ANTIHISTAMINE EYE DROPS

UP TO 12 HOURS

ALLERGY EYE ITCH RELIEF WORKS IN MINUTES!

▪ Original Prescription Strength

▪ For ages 3 years and older

[image – Bottle]

STERILE 0.34 FL OZ (10 mL)

ALAWAY 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24208-601
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (KETOTIFEN) KETOTIFEN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
SODIUM HYDROXIDE 
HYDROCHLORIC ACID 
WATER 
BENZALKONIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:24208-601-101 BOTTLE, DROPPER in 1 CARTON
110 mL in 1 BOTTLE, DROPPER
2NDC:24208-601-951 BOTTLE, DROPPER in 1 CARTON
21 mL in 1 BOTTLE, DROPPER
3NDC:24208-601-051 BOTTLE, DROPPER in 1 CARTON
35 mL in 1 BOTTLE, DROPPER
4NDC:24208-601-902 BOTTLE, DROPPER in 1 CARTON
410 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02199612/01/2006
Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
NameAddressID/FEIOperations
Bausch & Lomb Incorporated807927397MANUFACTURE(24208-601)

Revised: 04/2014
 
Bausch & Lomb Incorporated

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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