OLOPATADINE HYDROCHLORIDE solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM)
Available from:
Meijer
Administration route:
OPHTHALMIC
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander - if solution changes color or becomes cloudy - if you are sensitive to any ingredient in this product - to treat contact lens related irritation - eye pain - changes in vision - increased redness of the eye - itching worsens or lasts for more than 72 hours
Authorization status:
Abbreviated New Drug Application
Authorization number:
79481-1001-2, 79481-1001-4

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OLOPATADINE HYDROCHLORIDE - olopatadine hydrochloride solution

Meijer

----------

Drug Facts

Active ingredient

Olopatadine (0.2%)

(equivalent to olopatadine hydrochloride, USP 0.222%)

Purpos e

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:

consult a doctor

Other information

only for use in the eye

store between 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

Ques tions ?

1-855-274-4122

Distributed by:

MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

Made in India

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

Meijer NDC 79481-1001-2

olopatadine

hydrochloride ophthalm

solution USP, 0.2%

Antihis tamine

Eye Allergy Itch Relief

STERILE 2.5 mL (0.085 FL OZ)

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

meijer NDC 79481-1001-2

*Compare to Pataday

Once Daily

active ingredient

NOW AVAILABLE without

a prescription

olopatadine

hydrochloride

ophthalmic

solution USP, 0.2%

Antihis tamine

Eye Allergy Itch Relief

Works in Minutes, Relief from Allergens:

Pet Dander Pollen Grass Ragweed

ONCE

DAILY

STERILE

0.085 FL OZ (2.5 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton) Twin Pack

Twin Pack

meijer NDC 79481-1001-4

*Compare to Pataday

Once Daily

active ingredient

NOW AVAILABLE without

a prescription

olopatadine

hydrochloride

ophthalmic

solution USP, 0.2%

Antihistamine

Eye Allergy Itch Relief

Works in Minutes Relief from Allergens:

Pet Dander Pollen Grass Ragweed

ONCE

DAILY

STERILE

Two 2.5 mL Bottles

(0.085 FL OZ EACH)

OLOPATADINE HYDROCHLORIDE

olopatadine hydrochloride solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:79 48 1-10 0 1

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O LO PATADINE HYDRO CHLO RIDE (UNII: 2XG6 6 W44KF) (OLOPATADINE -

UNII:D27V6 19 0 PM)

OLOPATADINE

HYDROCHLORIDE

2 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

SO DIUM PHO SPHATE, DIBASIC, UNSPECIFIED FO RM (UNII: GR6 8 6 LBA74)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:79 48 1-10 0 1-

1 in 1 CARTON

0 7/15/20 20

1

2.5 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

2

NDC:79 48 1-10 0 1-

2 in 1 CARTON

0 7/15/20 20

2

2.5 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 9 9 9 5

0 7/15/20 20

Labeler -

Meijer (006959555)

Registrant -

Aurobindo Pharma Limited (650082092)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Auro bindo Pharma Limited

6 50 49 8 244

ANALYSIS(79 48 1-10 0 1) , MANUFACTURE(79 48 1-10 0 1)

Me ije r

Revised: 1/2021

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