Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 86aa9813-351c-4fbe-80f6-4f861f25fe1d
Route
ORAL
Published
Effective Date 2020-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Esomeprazole (20 mg)
Inactive Ingredients
Ferrosoferric Oxide Gelatin, Unspecified Hydroxypropyl Cellulose, Unspecified Hypromellose 2208 (100 Mpa.s) Magnesium Stearate Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Polysorbate 80 Potassium Hydroxide Propylene Glycol Shellac Talc Titanium Dioxide Triethyl Citrate Starch, Corn Sucrose Fd&c Blue No. 1 Fd&c Red No. 3 Glyceryl Monostearate

Identifiers & Packaging

Pill Appearance
Imprint: rg;50 Shape: capsule Color: pink Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2019-11-30

Description

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


Medication Information

Warnings and Precautions

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.

Indications and Usage
  • 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
Dosage and Administration
  • 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.
Description

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

Section 50565-1

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

Section 50566-9
  • 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
Section 50568-5
  • taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Section 50569-3
  • 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
Section 51727-6

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.

Section 51945-4

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

Section 53413-1

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

Section 53414-9

ask a health professional before use.

Section 55105-1

Acid reducer

Section 55106-9

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

Section 60561-8
  • 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.

Structured Label Content

Indications and Usage (34067-9)
  • 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
Dosage and Administration (34068-7)
  • 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.
Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)
  • 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
Section 50568-5 (50568-5)
  • taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Section 50569-3 (50569-3)
  • 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
Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Acid reducer

Section 55106-9 (55106-9)

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

Section 60561-8 (60561-8)
  • 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.

Advanced Ingredient Data


Raw Label Data

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