PATADAY ONCE DAILY RELIEF- olopatadine hydrochloride solution

PATADAY ONCE DAILY RELIEF by

Drug Labeling and Warnings

PATADAY ONCE DAILY 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 0.2% (equivalent to olopatadine hydrochloride 0.222%): Antihistamine

INDICATIONS & USAGE

Use temporarily relieves itchy 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) 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 between 2°-25°C (36°-77°F)

Inactive ingredients

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

Questions?

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

PRINCIPAL DISPLAY PANEL

NOW AVAILABLE
without a prescription

Pataday®
ONCE DAILY RELIEF
Olopatadine hydrochloride
ophthalmic solution 0.2%
Antihistamine

Eye Allergy Itch Relief

ONCE DAILY

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

STERILE
2.5 mL (0.085 FL OZ) 

Alcon  

Pataday®

ONCE DAILY RELIEF  

Eye Allergy Itch Relief
Works in Minutes

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. 

For Ages 2 and Older
30 DAY SUPPLY 

________Fill Line________  

6201 South Freeway
Fort Worth, Texas 76134
Country of Origin: Japan

ACTUAL SIZE 

NDC: 0065-8150-01  
9017921-1219 

Pataday®
ONCE DAILY RELIEF
Olopatadine hydrochloride 
ophthalmic solution 0.2% Antihistamine

2.5 mL (0.085 FL OZ)
STERILE

EYE ALLERGY ITCH RELIEF
Only for use in the eye. Store between 2°– 25° C (36°– 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.
Fort Worth, TX 76134

LOT:          EXP.:

H15725-219 

INGREDIENTS AND APPEARANCE

PATADAY ONCE DAILY RELIEF 
olopatadine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-8150
Route of Administration	OPHTHALMIC

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

Inactive Ingredients
Ingredient Name	Strength
Povidone, Unspecified (UNII: FZ989GH94E)
Sodium Phosphate, Dibasic, Unspecified Form (UNII: GR686LBA74)
Sodium Chloride (UNII: 451W47IQ8X)
Edetate Disodium (UNII: 7FLD91C86K)
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: 0065-8150-01	1 in 1 CARTON	02/28/2020
1		2.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 0065-8150-03	2 in 1 CARTON	02/28/2020
2		2.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 0065-8150-04	1 in 1 CARTON	02/28/2020
3		0.5 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	NDA021545	02/28/2020

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Research LLC		007672236	manufacture(0065-8150)