THERATEARS EXTRA- carboxymethylcellulose sodium, unspecified form 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 carboxymethylcellulose 0.25%

Purpose

Eye lubricant

Uses

•: For use as a protectant against further irritation or to relieve dryness of the eye.
•: For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

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 right away.

Directions

Instill 1 or 2 drops of TheraTears® Extra in the affected eye(s) as needed.

Other information

•: Do not use if neck ring is broken or missing.

Inactive ingredients

Boric acid, calcium chloride, Dequest®, potassium chloride, sodium bicarbonate, sodium borate, sodium chloride, magnesium chloride, sodium perborate, sodium phosphate, trehalose, and water for injection.

Questions or comments?

1-800-579-8327

Principal Display Panel Text for Container Label:

thera

tears®

THERAPY FOR YOUR EYES®

EXTRA

dry eye therapy

LUBRICANT

EYE DROPS

STERILE

0.5 FL OZ (15mL)

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

new!

RECOMMENDED

DOCTOR

CREATED

thera

tears®

THERAPY FOR YOUR EYES®

EXTRA

dry eye therapy

LUBRICANT

EYE DROPS

EXTRA MOISTURIZING

√ Rehydrates

√ Protects

√ Supports pH Level

STERILE

Multi-Use

Bottle* 0.5 FL OZ (15mL)

Principal Display Panel Text for Carton Label

THERATEARS EXTRA
carboxymethylcellulose sodium, unspecified form solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76688-002
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)
calcium chloride (UNII: M4I0D6VV5M)
Diethylenetriamine Pentamethylene Phosphonic Acid (UNII: 0Q75589TM3)
potassium chloride (UNII: 660YQ98I10)
sodium bicarbonate (UNII: 8MDF5V39QO)
sodium borate (UNII: 91MBZ8H3QO)
sodium chloride (UNII: 451W47IQ8X)
magnesium chloride (UNII: 02F3473H9O)
sodium perborate (UNII: Y52BK1W96C)
sodium phosphate (UNII: SE337SVY37)
trehalose (UNII: B8WCK70T7I)
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76688-002-70	1 in 1 CARTON	04/16/2018
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC:76688-002-72	2 in 1 CARTON	04/16/2018
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	04/16/2018

Labeler - Akorn AG (482198285)

Registrant - Akorn Operating Company LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn AG		482198285	PACK(76688-002) , LABEL(76688-002) , MANUFACTURE(76688-002) , ANALYSIS(76688-002)

Revised: 10/2020

Document Id: 75f63b76-4b15-4c79-a191-290b8b697dd8

Set id: 5870d78c-4ac5-4dc3-bf66-2aaac7dc504a

Version: 2

Effective Time: 20201019

Akorn AG