Tears Again

Manufacturer
OCuSOFT, Inc.
Effective date
2021-10-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:30:41

Label at a glance#

ProductTears Again
Active ingredientPolyvinyl Alcohol, Unspecified
Label structure12 sections

Indications and uses

for the temporary relief of burning and irritation due to dryness of the eye.

Dosage and administration

Instill 1 or 2 drops in the affected eye(s) as needed.

Storage and handling

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientPurpose
Polyvinyl Alcohol 1.4%Eye Lubricant

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of burning and irritation due to dryness of the eye.

Warnings

WARNINGS SECTION

For use in the eyes only.

Do not use

OTC - DO NOT USE SECTION

  • if solution changes color, or becomes cloudy.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton
Carton

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54799-904-15ML - Milliliter54799-90421d2c0d7-1148-4438-8315-fbacc629feb712019-08-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54799-90454799-904-15, 54799-904-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a8479ee7-461e-4378-b2a4-57e977b3bc2aeac4e03d-93c4-49ae-bcf7-32f1a6e59b4c2021-10-25WarningsExact identifier
spl id: a8479ee7-461e-4378-b2a4-57e977b3bc2a
spl set id: eac4e03d-93c4-49ae-bcf7-32f1a6e59b4c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.