Esomeprazole Magnesium — v2

Esomeprazole Magnesium

5 Views

Version

v2

Effective date

September 19, 2025

Original packager

Yes

Sections captured

17

Identifiers

Document ID
3f0b8002-cf27-0886-e063-6394a90a8271
Set ID
3863bc2c-3120-ad92-e063-6394a90abb20
Application numbers
ANDA217264
Product NDCs
79903-382
Package NDCs
79903-382-14, 79903-382-42
Original packager NDCs

Names & Manufacturers

Brand names
Esomeprazole Magnesium
Generic names
ESOMEPRAZOLE MAGNESIUM
Manufacturer names
Walmart Inc.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
ESOMEPRAZOLE MAGNESIUM
Routes
ORAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
606726
UNII
R6DXU4WAY9
UPC
0681131089586

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each capsule) Esomeprazole 20 mg (Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)
Ask Doctor (1)

Sequence 1

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 Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Do Not Use (1)

Sequence 1

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.
Dosage And Administration (1)

Sequence 1

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 o swallow 1 capsule with a glass of water before eating in the morning o take every day for 14 days o do not take more than 1 capsule a day o swallow whole. Do not crush or chew capsules. o do not use for more than 14 days unless directed by your doctor Repeated 14-Day Courses (if needed) o you may repeat a 14-day course every 4 months o 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.
Inactive Ingredient (1)

Sequence 1

Inactive ingredients black iron oxide, eudragit, FD&C blue 1, FD&C red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate
Indications And Usage (1)

Sequence 1

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
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Package Label Principal Display Panel (1)

Sequence 1

esome-label-14s esome-ifc-42s
Pregnancy (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Acid Reducer
Questions (1)

Sequence 1

Questions or comments? Call 1-888-287-1915
Spl Product Data Elements (1)

Sequence 1

Esomeprazole Magnesium Esomeprazole Magnesium FD&C RED NO. 3 SHELLAC DIMETHICONE SUCROSE TALC FD&C BLUE NO. 1 GLYCERYL MONOSTEARATE FERROSOFERRIC OXIDE STARCH, CORN TRIETHYL CITRATE ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE SODIUM LAURYL SULFATE HYPROMELLOSE, UNSPECIFIED FERRIC OXIDE YELLOW MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER HYDROXYPROPYL CELLULOSE, UNSPECIFIED POTASSIUM HYDROXIDE GELATIN, UNSPECIFIED TITANIUM DIOXIDE POLYSORBATE 80 golden cap and violet transparent body having light violet to violet colour band 75
Spl Unclassified Section (2)

Sequence 1

Drug Facts Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

Sequence 2

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.
Stop Use (1)

Sequence 1

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
Storage And Handling (1)

Sequence 1

Other information read the directions and warnings before use keep the carton. It contains important information. store at 20-25°C (68-77°F)
Warnings (1)

Sequence 1

Warnings Allergy alert • Do not use if you are allergic to esomeprazole • Esomeprazole may cause severe skin reactions. Symptoms include: o skin reddening o blisters o rash If an allergic reaction occurs, stop use and seek medical attention right away. 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 (1-800-222-1222) right away.

OpenFDA raw payload

{'application_number': ['ANDA217264'],
 'brand_name': ['Esomeprazole Magnesium'],
 'generic_name': ['ESOMEPRAZOLE MAGNESIUM'],
 'is_original_packager': [True],
 'manufacturer_name': ['Walmart Inc.'],
 'package_ndc': ['79903-382-14', '79903-382-42'],
 'product_ndc': ['79903-382'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['606726'],
 'spl_id': ['3f0b8002-cf27-0886-e063-6394a90a8271'],
 'spl_set_id': ['3863bc2c-3120-ad92-e063-6394a90abb20'],
 'substance_name': ['ESOMEPRAZOLE MAGNESIUM'],
 'unii': ['R6DXU4WAY9'],
 'upc': ['0681131089586']}