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

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TheraTears

Advanced Vision Research (Subsidiary of Akorn, Inc.)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (In each unit dose)

sodium carboxymethylcellulose 1%

Purpose

eye lubricant

Uses

  • As a lubricant to relieve dryness of the eye.
  • As a protectant against further irritation of the eye.
  • For temporary relief of burning, irritation, and discomfort including exposure to wind or sun.

Warnings

For external use only

  • To avoid contamination do not touch tip of opened container to any surface. Do not reuse. Once opened discard. Use individual vials within 90 days of opening foil pouch.

Do not use

  • if solution changes color or becomes cloudy

Stop use and ask a doctor if

  • you experience eye pain, changes in vision, continued redness or irritation
  • 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

  • To open, twist tab completely off.
  • Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

  • Use only if foil pouch is sealed and single-use container is intact.
  • Do not touch unit-dose tip to eye.

Inactive ingredients

borate buffers, calcium chloride, magnesium chloride, potassium chloride, purified water, sodium bicarbonate, sodium chloride and sodium phosphate

Principal Display Panel Text for Container Label:

PRESERVATIVE-FREE

Thera Tears logo

Liquid Gel

Lubricant Eye Gel

Soothing, Longer-Lasting

Relief & Protection!

  • Great for Nighttime &
    Extra Strength for Daytime
  • Replicates Human Tears

4 sterile 0.02 FLOZ

single-use containers

ADVANCED

VISION RESEARCH logo

AN AKORN COMPANY 0.08 FL OZ (2.4mL) TOTAL

Principal Display Panel Text for Carton Label:

PRESERVATIVE-FREE

Thera Tears logo

Liquid Gel

Lubricant Eye Gel

Soothing, Longer-Lasting

Relief & Protection!

  • Great for Nighttime
    & Extra Strength
    for Daytime
  • Replicates
    Human Tears

Sterile

28

Single-Use

ADVANCED Containers

VISION RESEARCH logo

AN AKORN COMPANY 0.57 FL OZ (16.8mL) TOTAL

TheraTears

carboxymethylcellulose sodium GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58790-002
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CARBOXYMETHYLCELLULOSE SODIUM 10 mg

Inactive Ingredients

Ingredient Name Strength
BORIC ACID
SODIUM BORATE
calcium chloride
MAGNESIUM CHLORIDE
potassium chloride
water
SODIUM BICARBONATE
SODIUM CHLORIDE
sodium phosphate

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 0.6 in 1 POUCH
2 NDC:58790-002-28 7 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part349 2002-12-01


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