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  5. Label Information: Olopatadine

FDA Label for Olopatadine

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THE PRODUCT
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Olopatadine Product Label

The following document was submitted to the FDA by the labeler of this product Akorn. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Olopatadine (0.2%)

(equivalent to olopatadine hydrochloride 0.222%)


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 The 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

Otc - Stop Use



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

Otc - Keep Out Of Reach Of Children



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 of age and older:
    • put 1 drop in the affected eye(s) once daily, no more than once 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 at 4° to 25°C (39° to 77°F).

Inactive Ingredients



benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, sodium chloride, and water for injection


Questions?



Call toll-Free 1-800-932-5676 weekdays, 7:00 AM - 5:30 PM CST


Package Label.Principal Display Panel



Principal Display Panel Text for Container Label:

NDC 17478-312-12

Olopatadine HCl Ophthalmic

Solution, USP 0.2%

Antihistamine

ONCE DAILY

STERILE 2.5 mL (0.085 FL OZ)

Principal Display Panel Text for Carton Label:

Original NDC 17478-312-12

Prescription

Strength Akorn logo

Olopatadine

HCl Ophthalmic

Solution, USP

0.2%

Antihistamine

Eye Allergy Itch Relief

Works in Minutes

Relief from Allergens:

• Pet Dander

• Pollen

• Grass

• Ragweed

ONCE DAILY

STERILE

2.5 mL (0.085 FL OZ)


* Please review the disclaimer below.