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TheraTears Lubricant by Advanced Vision Research (Subsidiary of Akorn, Inc.)

Medically reviewed on November 28, 2017

Dosage form: solution/ drops
Ingredients: carboxymethylcellulose sodium 2.5mg in 1mL
Labeler: Advanced Vision Research (Subsidiary of Akorn, Inc.)
NDC Code: 58790-000

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (In each unit dose)

Sodium Carboxymethylcellulose 0.25%

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

Lubricant Eye Drops

Soothing Dry-Eye

Relief that Works!

● Preservative Free

for Sensitive Eyes

● 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

Lubricant Eye Drops

Soothing Dry-Eye Relief

that Works!

● Preservative Free

for Sensitive Eyes

● Replicates

Human Tears

Sterile

32

Single-Use

ADVANCED Containers

VISION RESEARCH logo

AN AKORN COMPANY 0.65 FL OZ (19.2mL) TOTAL

THERATEARS LUBRICANT 
carboxymethylcellulose sodium solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58790-000
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
carboxymethylcellulose sodium (carboxymethylcellulose) carboxymethylcellulose sodium2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
boric acid 
sodium borate 
calcium chloride 
magnesium chloride 
potassium chloride 
water 
sodium bicarbonate 
sodium chloride 
sodium phosphate 
Packaging
#Item CodePackage Description
1NDC:58790-000-328 POUCH in 1 CARTON
14 APPLICATOR in 1 POUCH
119.2 mL in 1 APPLICATOR
2NDC:58790-000-246 POUCH in 1 CARTON
24 APPLICATOR in 1 POUCH
219.2 mL in 1 APPLICATOR
3NDC:58790-000-205 POUCH in 1 CARTON
34 APPLICATOR in 1 POUCH
319.2 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34901/01/1995
Labeler - Advanced Vision Research (Subsidiary of Akorn, Inc.) (969124536)

 
Advanced Vision Research (Subsidiary of Akorn, Inc.)

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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