Alaway Drug Facts

Dosage Form: eye drops
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

benzalkorium 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

60 Day Supply

Up To 12 Hours

Eye Itch Relief in Minutes!

▪ Original Prescription Strength

▪ Adults and children 3 years and older

STERILE 0.34 FL OZ (10 mL)

ALAWAY  ketotifen fumarate  solution/ drops

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 24208-601 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOTIFEN FUMARATE (KETOTIFEN) KETOTIFEN FUMARATE 0.345 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN   SODIUM HYDROXIDE   HYDROCHLORIC ACID   WATER   BENZALKONIUM CHLORIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 24208-601-10 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 1 10 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-601-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021996	12/01/2006

Labeler - Bausch & Lomb Incorporated (807927397)

Establishment
Name	Address	ID/FEI	Operations
Bausch & Lomb Incorporated		807927397	ANALYSIS, LABEL, MANUFACTURE, PACK, RELABEL, REPACK, STERILIZE

Establishment
Name	Address	ID/FEI	Operations
SIFAVITOR S.r.l.		338490579	ANALYSIS, API MANUFACTURE

Revised: 04/2010Bausch & Lomb Incorporated

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