THERATEARS DRY AND TIRED- carboxymethylcellulose sodium solution/ drops

TheraTears Dry and Tired by

Drug Labeling and Warnings

TheraTears Dry and Tired by is a Otc medication manufactured, distributed, or labeled by MEDTECH PRODUCTS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

THERATEARS LUBRICANT- carboxymethylcellulose sodium solution/ drops 
Medtech Products Inc., a Prestige Consumer Healthcare company

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 (In each unit dose)

Sodium Carboxymethylcellulose 0.5%

Purpose

Eye lubricant

Uses

• For the temporary relief of burning and irritation due to dryness of the eye.
  
• For the temporary relief of discomfort due to minor irritations of the eye or from exposure to wind and sun.
  
• For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

Warnings

For use in the eyes only.

Do not use

if solution changes color or becomes cloudy.

When using this product

■ do not touch tip of container to any surface to avoid contamination.

■ do not reuse; once opened discard.

Stop use and ask a doctor if

■ you experience eye pain, changes in vision, continued redness or irritation of the eye.

■ the 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

• To open, twist tab completely off.
  
• Instill 1 or 2 drops into affected eye(s) as needed and discard container.

Other information

• Store between 15º-30ºC (59º-86ºF).

Inactive ingredients

Calcium chloride, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium lactate. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions and comments?

1-800-579-8327

Principal Display Panel

Carboxymethylcellulose sodium 0.5%

LUBRICANT EYE DROPS

DRY & TIRED

dry eye therapy

PRESERVATIVE FREE

30 STERILE

Single-Use Vials

0.4 FL OZ (12 mL) TOTAL

INGREDIENTS AND APPEARANCE

THERATEARS DRY AND TIRED 
carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58790-013
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X)	CARBOXYMETHYLCELLULOSE SODIUM	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LACTATE (UNII: TU7HW0W0QT)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58790-013-30	6 in 1 CARTON	01/30/2026
1		5 in 1 POUCH
1		0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	01/30/2026

Labeler - MEDTECH PRODUCTS INC (114707784)