Olopatadine Hydrochloride Ophthalmic Solution
FDA Label NDC 51316-567

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Olopatadine Hydrochloride Ophthalmic Solution (NDC 51316-567). 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, purpose, use, warnings, do not use, when using this product, stop use and ask doctor if, 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

Olopatadine (0.7%) (equivalent to olopatadine hydrochloride 0.776%)

Purpose

Antihistamine


Use

temporarily relieves itchy 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 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(1-800-222-1222).

Directions

  • adults and children 2 years of age and older:
  • put 1 drop in the affected eye(s) once daily
  • do not use more than 1 drop in each eye 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 2° to 25°C (36° to 77°F)

Inactive Ingredients

benzalkonium chloride 0.015% (preservative), boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropyl gamma cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone and purified water.

Questions?

call toll-free weekdays 8 AM to 8 PM EST at 1-888-375-3784

Distributed by:

CVS Pharmacy Inc.

One CVS Drive

Woonsocket, RI 02895

Made in India

Principal Display Panel

Carton Label:


EXTRA STRENGTH
Olopatadine
Hydrochloride
Ophthalmic
Solution, USP
0.7%
Antihistamine
ONCE DAILY RELIEF
Eye Allergy Itch Relief
2.5 mL (0.085 fl oz)
Sterile 




Bottle Label:

EXTRA STRENGTH
Olopatadine
Hydrochloride
Ophthalmic
Solution, USP
0.7%
Antihistamine
ONCE DAILY RELIEF
Eye Allergy Itch Relief
2.5 mL (0.085 fl oz)
Sterile 


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