ESOMEPRAZOLE MAGNESIUM capsule, delayed release

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

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Active ingredient:
ESOMEPRAZOLE MAGNESIUM DIHYDRATE (UNII: 36H71644EQ) (ESOMEPRAZOLE - UNII:N3PA6559FT)
Available from:
Aurohealth LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acid reducer - treats frequent heartburn (occurs 2 or more days a week) - not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect - trouble or pain swallowing food, vomiting with blood, or bloody or black stools - heartburn with lightheadedness, sweating or dizziness - chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness - frequent chest pain These may be signs of a serious condition. See your doctor. - had heartburn over 3 months. This may be a sign of a more serious condition. - frequent wheezing, particularly with heartburn - unexplained weight loss - nausea or vomiting - stomach pain -  taking a prescription drug. Acid reducers may interact with certain prescription drugs. - your heartburn continues or worsens - you need to take this product for more than 14 days - you need to take more than 1 course of treatment every 4 months - you get diarrhea - you develop a rash or joint pain If pregnant
Authorization status:
Abbreviated New Drug Application
Authorization number:
58602-809-05, 58602-809-61, 58602-809-62

ESOMEPRAZOLE MAGNESIUM - esomeprazole magnesium capsule, delayed release

Aurohealth LLC

----------

Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg*

Drug Facts

Active ingredient (in each capsule)

*Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)

Purpose

Acid reducer

Uses

treats frequent heartburn (occurs 2 or more days a week)

not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Warnings

Allergy alert: Do not use if you are allergic to esomeprazole

Do not use if you have:

trouble or pain swallowing food, vomiting with blood, or bloody or black stools

heartburn with lightheadedness, sweating or dizziness

chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or

shoulders; or lightheadedness

frequent chest pain

These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have

had heartburn over 3 months. This may be a sign of a more serious condition.

frequent wheezing, particularly with heartburn

unexplained weight loss

nausea or vomiting

stomach pain

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

your heartburn continues or worsens

you need to take this product for more than 14 days

you need to take more than 1 course of treatment every 4 months

you get diarrhea

you develop a rash or joint pain

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

adults 18 years of age and older

this product is to be used once a day (every 24 hours), every day for 14 days

may take 1 to 4 days for full effect

14-Day Course of Treatment

swallow 1 capsule with a glass of water before eating in the morning

take every day for 14 days

do not take more than 1 capsule a day

swallow whole. Do not crush or chew capsules.

do not use for more than 14 days unless directed by your doctor

Repeated 14-Day Courses (if needed)

you may repeat a 14-day course every 4 months

do not take for more than 14 days or more often than every 4 months unless directed by a

doctor

children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be

caused by a serious condition.

Other information

read the directions and warnings before use

keep the carton. It contains important information.

store at 20-25°C (68-77°F)

Meets USP dissolution test 2

Inactive ingredients

colloidal silicon dioxide, FD&C blue no.1, gelatin, hydroxypropyl cellulose, hypromellose,

magnesium carbonate, magnesium oxide, methacrylic acid copolymer dispersion, mono and di

glycerides, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution,

sugar spheres (which contains liquid glucose, starch (maize) and sucrose), talc, titanium dioxide,

triethyl citrate and yellow iron oxide.

Questions or comments?

call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike,

Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Label)

AUROHEALTH

NDC 58602-809-05

Esomeprazole Magnesium

Delayed-Releas e

Capsules USP 20 mg*

Acid Reducer

24 HR

May take 1 to 4 days

for full effect

Treats Frequent Heartburn

14 Capsules

One 14-day course of treatment

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Carton)

#Compare to Nexium 24 HR Active ingredient

AUROHEALTH

NDC 58602-809-05

See new warning information

Esomeprazole Magnesium

Delayed-Release Capsules USP

20 mg*

Acid Reducer

24 HR

Treats Frequent Heartburn

May take 1 to 4 days for full effect

14 Capsules

One 14-day Course of treatment

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (28 Capsule Container Carton)

#Compare to Nexium 24 HR Active ingredient

AUROHEALTH

NDC 58602-809-61

See new warning information

Esomeprazole Magnesium

Delayed-Release Capsules USP

20 mg*

Acid Reducer

24 HR

Treats Frequent Heartburn

May take 1 to 4 days for full effect

28 Capsules

(2 bottles of 14 each)

Two 14-day courses of treatment

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Carton)

AUROHEALTH

NDC 58602-809-05

#Compare to Nexium 24 HR Active ingredient

See new warning information

Esomeprazole Magnesium

Delayed-Release

Capsules USP

20 mg*

Acid Reducer

24 HR

Treats Frequent Heartburn

May take 1 to 4 days for full effect

14 Capsules

One 14-day Course of treatment

ESOMEPRAZOLE MAGNESIUM

esomeprazole magnesium capsule, delayed release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 6 0 2-8 0 9

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

ESO MEPRAZO LE MAGNESIUM DIHYDRATE (UNII: 36 H716 44EQ) (ESOMEPRAZOLE -

UNII:N3PA6 559 FT)

ESOMEPRAZOLE

20 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

HYDRO XYPRO PYL CELLULO SE, UNSPECIFIED (UNII: 9 XZ8 H6 N6 OH)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

MAGNESIUM CARBO NATE (UNII: 0 E53J9 27NA)

MAGNESIUM O XIDE (UNII: 3A3U0 GI71G)

METHACRYLIC ACID - ETHYL ACRYLATE CO PO LYMER ( 1:1) TYPE A (UNII: NX76 LV5T8 J)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SHELLAC (UNII: 46 N10 7B71O)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

AMMO NIA (UNII: 5138 Q19 F1X)

DEXTRO SE, UNSPECIFIED FO RM (UNII: IY9 XDZ35W2)

STARCH, CO RN (UNII: O8 232NY3SJ)

SUCRO SE (UNII: C151H8 M554)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIETHYL CITRATE (UNII: 8 Z9 6 QXD6 UM)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

CAPSULE

S iz e

14mm

Flavor

Imprint Code

I8 1

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 6 0 2-8 0 9 -0 5

1 in 1 CARTON

10 /16 /20 17

1

14 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:58 6 0 2-8 0 9 -6 1

2 in 1 CARTON

10 /16 /20 17

2

14 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:58 6 0 2-8 0 9 -6 2

3 in 1 CARTON

10 /16 /20 17

3

14 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 9 339

10 /16 /20 17

Labeler -

Aurohealth LLC (078728447)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Auro bindo Pharma Limited

6 50 38 19 0 3

ANALYSIS(58 6 0 2-8 0 9 ) , MANUFACTURE(58 6 0 2-8 0 9 )

Aurohealth LLC

Revised: 4/2020

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