Olopatadine Hydrochloride Solution/ Drops
FDA Label NDC 51407-663

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Golden State Medical Supply, Inc. for the product Olopatadine Hydrochloride (NDC 51407-663). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if you experience :, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Olopatadine (01.%) (equivalent to olopatadine hydrochloride 0.111%)

                                 

Purpose

Antihistamine and redness reliever

Uses

Temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander.

Warnings

For external use only

Do Not Use

  • If solution changes color or becomes cloudy
  • If you are sensitive to any ingredient in this product
  • To treat contact lens related irritation

When Using This Product

  • Do not touch tip of container to any surface to avoid contamination
  • Remove contact lenses before use
  • Wait at least 10 minutes before reinserting contact lenses after use
  • Do not wear a contact lens if your eye is red

Stop Use And Ask A Doctor If You Experience :

  • Eye pain
  • Changes in vision
  • Increased redness of the eye
  • Itching worsens or lasts 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

  • adults and children 2 years and older:
    • put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice per day
      • if using other ophthalmic products while using this product, wait at least 5 minutes between each product
        • replace cap after each use
        • children under 2 years of age:

          • Consult a doctor

Other Information

  • Only for use in the eye
  • Store between 4°C to 25°C (39°F to 77°F)

Inactive Ingredients

benzalkonium chloride 0.01%, dibasic sodium phosphate (anhydrous), hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water and sodium chloride

Questions?

1-800-706-5575

Principal Display Panel

TWICE DAILY RELIEF

Olopatadine HCl Ophthalmic Solution, USP 0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

NDC 51407-663-05

51407-663-05.jpg (51407 663 05)

51407-663-05.jpg (51407 663 05)

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