THERATEARS LUBRICANT- carboxymethylcellulose sodium solution/ drops
Akorn AG

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

•: 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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76688-001
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X)	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	2.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76688-001-30	1 in 1 CARTON	07/01/1999
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC:76688-001-15	1 in 1 CARTON	07/01/1999
2		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	07/01/1999

Labeler - Akorn AG (482198285)

Registrant - Akorn Operating Company LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn AG		482198285	MANUFACTURE(76688-001) , PACK(76688-001) , ANALYSIS(76688-001)

Revised: 10/2020

Document Id: 5fd3b20c-970c-4541-8133-336a8047100f

Set id: 56d2dea5-26c0-4612-a0f3-88ab4d4b93ee

Version: 2

Effective Time: 20201019

Akorn AG