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

Dosage form: solution/ drops
Ingredients: carboxymethylcellulose sodium 2.5mg in 1mL
Labeler: Advanced Vision Research (Subsidiary of Akorn, Inc.)
NDC Code: 58790-001

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

Sodium carboxy-
methylcellulose 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. Replace cap after using.

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 immediately.

Directions

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

Other information
  • Do not use if imprinted neckband is broken or missing.

Inactive ingredients

Borate buffers, calcium chloride, Dequest®, magnesium chloride, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium perborate, and sodium phosphate

Questions or comments?

1-800-579-8327

Principal Display Panel Text for Container Label:

thera

tears®

THERAPY FOR YOUR EYES

dry eye therapy

LUBRICANT

EYE DROPS

Principal Display Panel Text for Carton Label:

RECOMMENDED

DOCTOR

CREATED

thera

tears®

THERAPY FOR YOUR EYES®

dry eye therapy

LUBRICANT

EYE DROPS

RESTORES EYES

NATURAL BALANCE®

STERILE

Multi-Use

Bottle 1 FL OZ (30 mL)

THERATEARS LUBRICANT 
carboxymethylcellulose sodium solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58790-001
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 perborate 
calcium chloride 
diethylenetriamine pentamethylene phosphonic acid 
magnesium chloride 
potassium chloride 
water 
sodium bicarbonate 
sodium chloride 
sodium phosphate 
Packaging
#Item CodePackage Description
1NDC:58790-001-301 BOTTLE, DROPPER in 1 CARTON
130 mL in 1 BOTTLE, DROPPER
2NDC:58790-001-151 BOTTLE, DROPPER in 1 CARTON
215 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34907/01/1999
Labeler - Advanced Vision Research (Subsidiary of Akorn, Inc.) (969124536)
Establishment
NameAddressID/FEIOperations
Akorn, Inc063434679PACK(58790-001), LABEL(58790-001)
Establishment
NameAddressID/FEIOperations
Akorn, Inc155135783MANUFACTURE(58790-001), ANALYSIS(58790-001), STERILIZE(58790-001)

Revised: 04/2016
 
Advanced Vision Research (Subsidiary of Akorn, Inc.)

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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