Artificial Tears description, usages, side effects, indications, overdosage, supplying and lots more!

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Artificial Tears

Akorn, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Polyvinyl Alcohol 1.4%

Purpose

Eye lubricant

Uses

For use as a lubricant to prevent further Irritation or to relieve dryness of the eye(s)

Warnings

  • Do not use if imprinted seal on the bottle neck is broken or missing.
  • Do not use if solution changes color or becomes cloudy.
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.

Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists 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

Instill 1 or 2 drops In the affected eye(s) as needed.

Other information

  • Store at 20' to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • Store away from heat.
  • Protect from freezing.
  • Keep tightly closed.

    RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Benzalkonium Chloride 0.005% (preservative), Edetate Disodium, Sodium Chloride, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Purified Water USP, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH

Questions?

call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST

ATAKC
Rev. 09/11

Principal Display Panel Text for Container Label:

NDC 17478-060-12

Artificial

Tears

Solution

Polyvinyl

Alcohol 1.4%

Lubricant

Eye Drops

Sterile

15 mL (0.5 fl. oz.)

Principal Display Panel Text for Carton Label:

NDC 17478-060-12

15 mL

Artificial

Tears

Solution

Polyvinyl Alcohol 1.4%

Lubricant Eye Drops

Prevents Irritation and Relieves

Dryness of the Eye

Sterile

15 mL (0.5 fl. oz.)

Artificial Tears

Polyvinyl Alcohol SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:17478-060
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POLYVINYL ALCOHOL 14 mg

Inactive Ingredients

Ingredient Name Strength
EDETATE DISODIUM
SODIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC
sodium phosphate, monobasic
SODIUM HYDROXIDE
HYDROCHLORIC ACID
water
benzalkonium chloride

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BOTTLE, DROPPER
2 NDC:17478-060-12 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part349 1998-03-01


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