PATADAY TWICE A DAY RELIEF- olopatadine hydrochloride solution

PATADAY TWICE A DAY RELIEF by

Drug Labeling and Warnings

PATADAY TWICE A DAY RELIEF by is a Otc medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., Alcon Research LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active Ingredients: Purpose
• Olopatadine (0.1%). (equivalent to olopatadine hydrochloride 0.111%): Antihistamine and Redness Reliever

INDICATIONS & USAGE

Use temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander

WARNINGS

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

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

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) 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°-25°C (39°-77°F)

Inactive ingredients

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

Questions?

In the U.S., call 1-800-757-9195 or email alcon.medinfo@alcon.com

Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134
Country of Origin: Japan

NDC: 0065-4274-01
9017919-1219

PRINCIPAL DISPLAY PANEL

NOW AVAILABLE
without a prescription

Pataday®
TWICE DAILY RELIEF
Olopatadine hydrochloride
ophthalmic solution 0.1%
Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief
TWICE DAILY

Works in Minutes
Relief from Allergens:
    Pet Dander
    Pollen
     Grass
    Ragweed

STERILE
5 mL (0.17 FL OZ) 

Alcon  

Pataday®

TWICE DAILY RELIEF  
Eye Allergy Itch & Redness Relief
Works in Minutes

For Ages 2 and Older
30 DAY SUPPLY 

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. 

________Fill Line________ 

Do not use if seal is damaged or missing at time of purchase.  

ACTUAL SIZE 

Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134
Country of Origin: Japan 
 

NDC: 0065-4274-01   
9017919-1219 

LOT:     EXP.:

Pataday®
TWICE DAILY RELIEF
Olopatadine hydrochloride
ophthalmic solution 0.1%
Antihistamine and Redness Reliever
Eye Allergy Itch & Redness Relief

5 mL (0.17 FL OZ)
STERILE

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

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase. 

Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134 

LOT:          EXP.:

H15723-1219 

INGREDIENTS AND APPEARANCE

PATADAY TWICE A DAY RELIEF 
olopatadine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-4274
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Olopatadine Hydrochloride (UNII: 2XG66W44KF) (Olopatadine - UNII:D27V6190PM)	Olopatadine	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Sodium Phosphate, Dibasic, Unspecified Form (UNII: GR686LBA74)
Sodium Chloride (UNII: 451W47IQ8X)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-4274-01	1 in 1 CARTON	02/28/2020
1		5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020688	02/28/2020

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Research LLC		007672236	manufacture(0065-4274)