THERATEARS LUBRICANT- carboxymethylcellulose sodium solution/ drops

TheraTears Lubricant by

Drug Labeling and Warnings

TheraTears Lubricant by is a Otc medication manufactured, distributed, or labeled by Advanced Vision Research (Subsidiary of Akorn, Inc.), Akorn Operating Company LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (In each unit dose)

Sodium Carboxymethylcellulose 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. Do not reuse. Once opened discard. Use individual vials within 90 days of opening foil pouch.
• This product contains no preservatives. Any solution not used immediately after opening should be discarded. Re-use of this single-use product may lead to inflammation of the eye and/or discomfort, based on ptential contamination during handling.

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

• To open, twist tab completely off.
• Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

• Use only if foil pouch is sealed and single-use container is intact.
• Do not touch unit-dose tip to eye.

Inactive ingredients

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

Questions and comments?

1-800-579-8327

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

PRESERVATIVE FREE

thera

tears®

THERAPY FOR YOUR EYESTM

dry eye therapy

LUBRICANT

EYE DROPS

RESTORES EYES

NATURAL BALANCE™

4 Single-Use      STERILE

Vials      0.08 FL OZ (2.4mL) TOTAL

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

PRESERVATIVE

FREE

RECOMMENDED

DOCTOR

CREATED

thera

tears®

THERAPY FOR YOUR EYES®

dry eye therapy

LUBRICANT

EYE DROPS

IMMEDIATE

LONG LASTING

RELIEF

32 STERILE

Single-Use Vials*   0.65 FL OZ (19.2mL) TOTAL

INGREDIENTS AND APPEARANCE

THERATEARS LUBRICANT 
carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58790-000
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)
sodium borate (UNII: 91MBZ8H3QO)
calcium chloride (UNII: M4I0D6VV5M)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58790-000-32	8 in 1 CARTON	01/01/1995
1		4 in 1 POUCH
1		19.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 58790-000-24	6 in 1 CARTON	01/01/1995
2		4 in 1 POUCH
2		19.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
3	NDC: 58790-000-20	5 in 1 CARTON	01/01/1995
3		4 in 1 POUCH
3		19.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
4	NDC: 58790-000-30	5 in 1 CARTON	12/07/2018
4		6 in 1 POUCH
4		0.6 mL in 1 APPLICATOR; 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	01/01/1995

Labeler - Advanced Vision Research (Subsidiary of Akorn, Inc.) (969124536)