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Alaway

Bausch & Lomb Incorporated

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Ketotifen 0.025%
(equivalent to ketotifen fumerate 0.035%)

Purpose

Antihistamine

Alaway 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 Type Human otc drug label Item Code (Source) NDC:24208-601
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Ketotifen Fumarate Ketotifen 0.25 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
SODIUM HYDROXIDE
HYDROCHLORIC ACID
water
benzalkonium chloride

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BOTTLE, DROPPER
2 1 in 1 BOTTLE, DROPPER
3 5 in 1 BOTTLE, DROPPER
4 10 in 1 BOTTLE, DROPPER
5 NDC:24208-601-90 2 in 1 CARTON

Marketing Information

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


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Be sure to consult your doctor before taking any medication!
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