THERATEARS EXTRA- carboxymethylcellulose sodium, unspecified form solution/ drops

TheraTears Extra by

Drug Labeling and Warnings

TheraTears Extra by is a Otc medication manufactured, distributed, or labeled by Akorn AG, Akorn Operating Company LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311) (Carboxymethylcellulose - UNII:05JZI7B19X)	Carboxymethylcellulose Sodium, Unspecified Form	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	04/16/2018

Labeler - Akorn AG (482198285)

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