Label: THERATEARS EXTRA- carboxymethylcellulose sodium, unspecified form solution/ drops

  • NDC Code(s): 58790-007-15, 58790-007-16
  • Packager: MEDTECH PRODUCTS INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated March 8, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 risk of contamination do not touch tip of opened container to any surface. Replace cap tightly after each use.

    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.
    • Discard 45 days after opening.
  • Inactive ingredients

    Boric acid, calcium chloride, Dequest®, 2060S phosphonate, magnesium chloride, potassium chloride, sodium bicarbonate, sodium borate, sodium chloride, sodium perborate, sodium phosphate, trehalose, and water for injection.

  • Questions or comments?

    1-800-579-8327

  • Principal Display Panel Text for Container Label:

    thera

    tears®

    THERAPY FOR YOUR EYES®

    EXTRA®

    dry eye therapy

    LUBRICANT

    EYE DROPS

    EXTRA MOISTURIZING

    √ Rehydrates

    √ Protects

    √ Supports pH Level

    STERILE

    Multi-Use

    Bottle TWO 0.5 FL OZ (15 mL) BOTTLES

    thera tears® THERAPY FOR YOUR EYES® EXTRA® dry eye therapy LUBRICANT EYE DROPS EXTRA MOISTURIZING √ Rehydrates √ Protects √ Supports pH Level STERILE Multi-Use Bottle TWO 0.5 FL OZ (15 mL) BOTTLES

  • Principal Display Panel Text for Carton Label:

    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 (15 mL)

    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 (15 mL)

  • INGREDIENTS AND APPEARANCE
    THERATEARS EXTRA 
    carboxymethylcellulose sodium, unspecified form solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58790-007
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311) (Carboxymethylcellulose - UNII:05JZI7B19X) Carboxymethylcellulose Sodium, Unspecified Form2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58790-007-151 in 1 CARTON04/16/2018
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:58790-007-162 in 1 CARTON12/01/2020
    215 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34904/16/2018
    Labeler - MEDTECH PRODUCTS INC (114707784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn AG482198285analysis(58790-007) , label(58790-007) , manufacture(58790-007) , pack(58790-007)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!