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 (0.7%)(equivalent to olopatadine hydrochloride 0.776%): 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
  • 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°-25°C (36°-77°F)

Inactive ingredients

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

Questions?

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

PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH

Pataday®

ONCE DAILY RELIEF

Olopatadine hydrochloride
ophthalmic solution 0.7%
Antihistamine

Eye Allergy Itch Relief

FULL 24 HOUR

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

Alcon

STERILE
2.5 mL (0.085 FL OZ) 

EXTRA STRENGTH

Pataday®

ONCE DAILY RELIEF  

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. 

30 DAY SUPPLY

Eye Allergy Itch Relief 
Works in Minutes 
For Ages 2 and Older

________Fill Line________  

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

ACTUAL SIZE 

NDC: 0065-0816-04  
300038456-0620

LOT:                         EXP.:

3187 

EXTRA STRENGTH

Pataday®
ONCE DAILY RELIEF
Olopatadine hydrochloride 
ophthalmic solution 0.7% Antihistamine

2.5 mL (0.085 FL OZ)
STERILE

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.
6201 South Freeway
Fort Worth, TX 76134

LOT:          EXP.:

300038442-0620

INGREDIENTS AND APPEARANCE

PATADAY ONCE DAILY RELIEF 
olopatadine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-0816
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Olopatadine Hydrochloride (UNII: 2XG66W44KF) (Olopatadine - UNII:D27V6190PM)	Olopatadine	7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Boric Acid (UNII: R57ZHV85D4)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)
Hydroxypropyl .Gamma.-Cyclodextrin (UNII: P6BYU725IU)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Mannitol (UNII: 3OWL53L36A)
Polyethylene Glycol 400 (UNII: B697894SGQ)
Povidone, Unspecified (UNII: FZ989GH94E)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-0816-04	1 in 1 CARTON	09/01/2020
1		2.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 0065-0816-01	2 in 1 CARTON	01/04/2021
2		2.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 0065-0816-02	1 in 1 CARTON	01/04/2021
3		0.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 0065-0816-12	3 in 1 CARTON	01/24/2022
4		2.5 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	NDA206276	09/01/2020

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Research LLC		007672236	manufacture(0065-0816)