FDA Label for Olopatadine Hydrochloride

View Indications, Usage & Precautions

DRUG FACTS
PURPOSE
USE
WARNINGS
DO NOT USE
WHEN USING THIS PRODUCT
STOP USE AND ASK A DOCTOR IF YOU EXPERIENCE:
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS?
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 ML CONTAINER)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 ML CONTAINER CARTON)

Olopatadine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Amerisource Bergen. 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.

Drug Facts

Active ingredient
Olopatadine (0.2%)
(equivalent to olopatadine hydrochloride, USP 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 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 (1-800-222-1222) 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:

Other Information

only for use in the eye
store between 2° to 25°C (36° 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?

✆1-855-274-4122

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India
Code: TS/DRUGS/13/2010

Package Label-Principal Display Panel-0.2% (2.5 Ml Container)

GOOD
NEIGHBOR
PHARMACY^®                             NDC 46122-671-27
Olopatadine Hydrochloride
Ophthalmic Solution USP, 0.2%
Antihistamine
                                                     Eye Allergy Relief
STERILE                            2.5 mL (0.085 FL OZ)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container) - olopatadine fig1

Package Label-Principal Display Panel-0.2% (2.5 Ml Container Carton)

                                                  *Compare to the Active Ingredient
                                                         in Pataday^® Once Daily Relief
GOOD
NEIGHBOR
PHARMACY^®                             NDC 46122-671-27
NOW AVAILABLE without a prescription
Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.2%
Antihistamine
                                      Eye Allergy Relief
Works in Minutes
Relief from Allergens:
• Pet Dander • Pollen                     ONCE
• Grass • Ragweed                          DAILY
STERILE
2.5 mL (0.085 FL OZ)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton) - olopatadine fig2

* Please review the disclaimer below.

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