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NDC 63304-0740-14 Esomeprazole 20 mg/1 Details

Esomeprazole 20 mg/1

Esomeprazole is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is ESOMEPRAZOLE MAGNESIUM.

MedlinePlus Drug Summary

Prescription esomeprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription esomeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription esomeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD. Prescription esomeprazole is also used to decrease the chance that people who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) will develop ulcers (sores in the lining of the stomach or intestine) in adults. It is also used with other medications to treat and prevent the return of stomach ulcers caused by a certain type of bacteria (H. pylori) in adults. Prescription esomeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome in adults. Nonprescription (over-the-counter) esomeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 or more days a week) in adults. Esomeprazole is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach.

Related Packages: 63304-0740-14
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Esomeprazole

Product Information

NDC	63304-0740
Product ID	63304-740_6ac3f3a4-98df-4eb3-9b9e-c85253811b85
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Esomeprazole
Proprietary Name Suffix	n/a
Non-Proprietary Name	Esomeprazole
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, DELAYED RELEASE
Route	ORAL
Active Ingredient Strength	20
Active Ingredient Units	mg/1
Substance Name	ESOMEPRAZOLE MAGNESIUM
Labeler Name	Sun Pharmaceutical Industries, Inc.
Pharmaceutical Class	Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA212866
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63304-0740-14 (63304074014)

Pricing Information	N/A
NDC Package Code	63304-740-14
Billing NDC	63304074014
Package	1 BOTTLE in 1 CARTON (63304-740-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Start Date	2019-11-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 86aa9813-351c-4fbe-80f6-4f861f25fe1d Details

Active ingredient (in each capsule)

Esomeprazole 20 mg (Each delayed-release capsule contains 22.3 mg esomeprazole magnesium trihydrate)

Purpose

Acid reducer

Use

•: 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. Heartburn in children may sometimes be caused by a serious condition.

Other information

•: read the directions and warnings before use.
•: Store at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.]
•: keep the carton. It contains important information.

Inactive Ingredients

FD & C blue no 1, FD & C red no 3, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate.

Questions?

Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.

TAMPER-EVIDENT FEATURES: Do not use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” or blue band around center of each capsule is broken or missing.

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.

Manufactured by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

1019

Package/Label Principal Display Panel

NDC 63304-740-14

Treats Frequent Heartburn

Esomeprazole Magnesium Delayed-Release

Capsules USP,

20 mg

Acid Reducer

May take 1 to 4 days for full effect

ohm®

14 CAPSULES

One 14-day course of treatment

Principal Display Panel