ESOMEPRAZOLE MAGNESIUM capsule, delayed release

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

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Active ingredient:
Esomeprazole Magnesium (UNII: R6DXU4WAY9) (Esomeprazole - UNII:N3PA6559FT)
Available from:
The Kroger Co.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acid reducer - treats frequent heartburn (occurs 2 or more days a week) 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 not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
Authorization status:
Abbreviated New Drug Application
Authorization number:
30142-261-14, 30142-261-28, 30142-261-42

ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release

The Kroger Co.

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Drug Facts

Active ingredient(s) in each capsule

*Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 20.7 mg esomeprazole magnesium, USP)

Purpos e

Acid reducer

Us es

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 lightheadness

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

warfarin, clopidogrel or cilostazol (blood-thinning medicines)

prescription ant fungal or anti-yeast medicines

digoxin (heart medicine)

diazepam (anxiety medicine)

tacrolimus or mycophenolate mofetil (immune system medicine)

prescription antiretrovirals (medicines for HIV infection)

methotrexate (arthritis medicine)

Stop use and ask 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.

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

each capsule contains: magnesium, 15 mg

read directions and warnings before use

keep the carton. It contains important information

store at 20 to 25°C (68 to 77°F)

Inactive ingredients

acetyl tributyl citrate, dibutyl sebacate, FD&C Blue #1, ferroso ferric oxide, gelatin, glyceryl

monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid copolymer

dispersion, poloxamer, polysorbate 80, povidone, potassium hydroxide, propylene glycol, shellac,

sugar, talc, titanium dioxide

Questions or comments

call toll-free weekdays 8 AM to 10 PM EST at 1-888-375-3784

Tips for Managing Heartburn

Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried

foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.

Eat slowly and do not eat big meals.

Do not eat late at night or just before bedtime.

Do not lie flat or bend over soon after eating.

Raise the head of your bed.

Wear loose-fitting clothing around your stomach.

If you are overweight, lose weight.

If you smoke, quit smoking.

Container Label

Container Label

Carton label

Carton

ESOMEPRAZOLE MAGNESIUM

esomeprazole magnesium capsule, delayed release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:30 142-26 1(NDC:4359 8 -40 7)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Eso mepra zo le Ma g nesium (UNII: R6 DXU4WAY9 ) (Eso meprazo le - UNII:N3PA6 559 FT)

Eso me pra z o le

20 mg

Inactive Ingredients

Ingredient Name

Stre ng th

a cetyltributyl citra te (UNII: 0 ZBX0 N59 RZ)

Dibutyl Seba ca te (UNII: 4W5IH7FLNY)

Ferro so ferric O xide (UNII: XM0 M8 7F357)

Gela tin (UNII: 2G8 6 QN327L)

Glyceryl Mo no stea ra te (UNII: 230 OU9 XXE4)

Hypro mello ses (UNII: 3NXW29 V3WO)

Ma g nesium O xide (UNII: 3A3U0 GI71G)

Ma g nesium Stea ra te (UNII: 70 0 9 7M6 I30 )

Metha crylic Acid - Ethyl Acryla te Co po lymer ( 1:1) Type A (UNII: NX76 LV5T8 J)

Po lo xa mer 18 8 (UNII: LQA7B6 G8 JG)

The Kroger Co.

Po lyso rba te 8 0 (UNII: 6 OZP39 ZG8 H)

Po vido ne K3 0 (UNII: U725QWY32X)

Ta lc (UNII: 7SEV7J4R1U)

Tita nium Dio xide (UNII: 15FIX9 V2JP)

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

Po ta ssium Hydro xide (UNII: WZH3C48 M4T)

Shella c (UNII: 46 N10 7B71O)

Sucro se (UNII: C151H8 M554)

Fd&C Blue No . 1 (UNII: H3R47K3TBD)

Product Characteristics

Color

BLUE (light blue cap) , BLUE (dark blue bo dy)

S core

no sco re

S hap e

CAPSULE

S iz e

16 mm

Flavor

Imprint Code

RDY;327

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:30 142-26 1-14

1 in 1 CARTON

0 3/15/20 19

1

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

2

NDC:30 142-26 1-28

2 in 1 CARTON

0 3/15/20 19

2

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

3

NDC:30 142-26 1-42

3 in 1 CARTON

0 3/15/20 19

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 76 73

0 3/15/20 19

Labeler -

T he Kroger Co. (006999528)

Revised: 2/2020

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