BASIC CARE ESOMEPRAZOLE MAGNESIUM- esomeprazole capsule, delayed release

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

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Active ingredient:
ESOMEPRAZOLE (UNII: N3PA6559FT) (ESOMEPRAZOLE - UNII:N3PA6559FT)
Available from:
L. Perrigo Company
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acid reducer
Authorization status:
Abbreviated New Drug Application
Authorization number:
0113-0732-01, 0113-0732-03

BASIC CARE ESOMEPRAZOLE MAGNESIUM- esomeprazole capsule, delayed release

L. Perrigo Company

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Amazon Esomeprazole Magnesium Drug Facts

Active ingredient (in each capsule)

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22 mg esomeprazole magnesium dihydrate)

Purpos e

Acid reducer

Us es

Warnings

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

Do not use if you have:

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

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

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

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

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

14-Day Course of Treatment

Repeated 14-Day Courses (if needed)

Other information

Inactive ingredients

FD&C blue no. 1, FD&C red no. 3, ferric oxide, gelatin, glyceryl monostearate, hypromellose,

magnesium stearate, meglumine, methacrylic acid copolymer, polyethylene glycol, polysorbate 80,

shellac, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions or comments?

1-800-719-9260

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

you get diarrhea

you develop a rash or joint pain

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

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

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.

read the directions and warnings before use

keep the carton. It contains important information.

store at 20-25°C (68-77°F)

Package/Label Principal Display Panel

Compare to Nexium® 24 HR active ingredient

Capsules

esomeprazole magnesium delayed-release capsules, 20 mg / Acid Reducer

Treats Frequent Heartburn

24 HR

actual size

May take 1 to 4 days for full effect

See new warning information

42 CAPSULES

three 14-day courses of treatment

BASIC CARE ESOMEPRAZOLE MAGNESIUM

esomeprazole capsule, delayed release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 113-0 732

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ESO MEPRAZO LE (UNII: N3PA6 559 FT) (ESOMEPRAZOLE - UNII:N3PA6 559 FT)

ESOMEPRAZOLE

20 mg

Inactive Ingredients

Ingredient Name

Stre ng th

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

FD&C RED NO . 3 (UNII: PN2ZH5LOQY)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

GELATIN (UNII: 2G8 6 QN327L)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MEGLUMINE (UNII: 6 HG8 UB2MUY)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

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

SHELLAC (UNII: 46 N10 7B71O)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIETHYL CITRATE (UNII: 8 Z9 6 QXD6 UM)

Product Characteristics

Color

BLUE (o paque)

S core

no sco re

S hap e

CAPSULE (o blo ng)

S iz e

14mm

Flavor

Imprint Code

L8 9 8

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 113-0 732-0 1

1 in 1 CARTON

0 1/0 9 /20 18

1

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

2

NDC:0 113-0 732-0 3

3 in 1 CARTON

0 1/0 9 /20 18

2

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

Marketing Information

L. Perrigo Company

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 719 3

0 1/0 9 /20 18

Labeler -

L. Perrigo Company (006013346)

Revised: 10/2019

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