TEARS AGAIN- benzalkonium chloride, sodium phosphate, dibasic, edetate disodium,sodium phosphate, monobasic, sodium chloride, water, phosphoric acid, sodium hydroxide solution

Tears Again by

Drug Labeling and Warnings

Tears Again by is a Otc medication manufactured, distributed, or labeled by OCuSOFT, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

• Active Ingredient: Purpose
• Polyvinyl Alcohol 1.4%: Eye Lubricant

Uses

• for the temporary relief of burning and irritation due to 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

• avoid contamination, do not touch tip of container to any surface.
• replace cap after using.
• remove contact lenses before use.

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 this and all drugs 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

• Store at room temperature 15°-30°C (between 59°-86°F).
• Keep tightly closed.
• Do not use if imprinted seal on cap is torn, broken or missing.
• Refer to carton for full product information.

Inactive Ingredients

Benzalkonium Chloride, Dibasic Sodium Phosphate, Edetate Disodium, Monobasic Sodium Phosphate, Sodium Chloride, and Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH.

Questions

Call (800) 223-5469 M-F 8:30AM - 5:00PM CST or visit www.ocusoft.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 54799-904-15

Tears Again®
EYE DROPS
Sterile Lubricant

Polyvinyl Alcohol 1.4%

Gentle, Effective Relief for Dry, Irritated Eyes

OCuSOFT®

Net Wt 15 mL (0.5  fl oz)

For the Temporary Relief of Burning, Irritation and Discomfort Due to Dryness of the Eye

OCuSOFT®

Manufactured for OCuSOFT Inc.
Rosenberg, TX 77471 USA  

© 2018 OCuSOFT Inc.
® marks owned by OCuSOFT Inc.

777-3-15
R0918

INGREDIENTS AND APPEARANCE

TEARS AGAIN 
benzalkonium chloride, sodium phosphate, dibasic, edetate disodium,sodium phosphate, monobasic, sodium chloride, water, phosphoric acid, sodium hydroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54799-904
Route of Administration	INTRAOCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Polyvinyl Alcohol, Unspecified (UNII: 532B59J990) (Polyvinyl Alcohol, Unspecified - UNII:532B59J990)	Polyvinyl Alcohol, Unspecified	14 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Sodium Phosphate, Dibasic (UNII: GR686LBA74)
Edetate Disodium (UNII: 7FLD91C86K)
Sodium Phosphate, Monobasic (UNII: 3980JIH2SW)
Sodium Chloride (UNII: 451W47IQ8X)
Water (UNII: 059QF0KO0R)
Phosphoric Acid (UNII: E4GA8884NN)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54799-904-15	1 in 1 CARTON	08/01/2010
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 54799-904-30	1 in 1 CARTON	08/01/2018
2		30 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	08/01/2010

Labeler - OCuSOFT, Inc. (174939207)