THERATEARS LUBRICANT- carboxymethylcellulose sodium solution/ drops 
Advanced Vision Research (Subsidiary of Akorn, Inc.)

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.

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Drug Facts

Active ingredient

Sodium carboxy-
methylcellulose 0.25%

Purpose

Eye lubricant

Uses

Warnings

For external use only

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

Inactive ingredients

Borate buffers, calcium chloride, Dequest®, magnesium chloride, potassium chloride, sodium bicarbonate, sodium chloride, sodium perborate, sodium phosphate, and water for injection.

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

STERILE

1 FL OZ (30 mL)

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

VALUE SIZE

RECOMMENDED

DOCTOR

CREATED

thera

tears®

THERAPY FOR YOUR EYES®

dry eye therapy

LUBRICANT

EYE DROPS

IMMEDIATE

LONG LASTING

RELIEF

STERILE

Multi-Use Bottle*

1 FL OZ (30 mL)

Principal Display Panel Text for Carton Label
THERATEARS LUBRICANT 
carboxymethylcellulose sodium solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58790-001
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
carboxymethylcellulose sodium (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X) carboxymethylcellulose sodium2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
boric acid (UNII: R57ZHV85D4)  
sodium perborate (UNII: Y52BK1W96C)  
calcium chloride (UNII: M4I0D6VV5M)  
diethylenetriamine pentamethylene phosphonic acid (UNII: 0Q75589TM3)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
water (UNII: 059QF0KO0R)  
sodium bicarbonate (UNII: 8MDF5V39QO)  
sodium chloride (UNII: 451W47IQ8X)  
sodium phosphate (UNII: SE337SVY37)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58790-001-301 in 1 CARTON07/01/1999
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:58790-001-151 in 1 CARTON07/01/1999
215 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3NDC:58790-001-312 in 1 CARTON12/01/2020
330 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
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.) (117696736)
Registrant - Akorn Operating Company LLC (117693100)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc117696790PACK(58790-001) , LABEL(58790-001)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc117696832MANUFACTURE(58790-001) , ANALYSIS(58790-001) , STERILIZE(58790-001)
Establishment
NameAddressID/FEIBusiness Operations
Akorn AG482198285ANALYSIS(58790-001) , LABEL(58790-001) , MANUFACTURE(58790-001) , PACK(58790-001)

Revised: 10/2020
Document Id: 52e2ba56-dd7b-476a-9705-9fce71d4243f
Set id: 661d8764-8ae6-4229-9485-867553ee8e16
Version: 7
Effective Time: 20201008
 
Advanced Vision Research (Subsidiary of Akorn, Inc.)