Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID e6d19b0a-44a8-42fe-8a6c-717ecb3ac1c4
Route
ORAL
Published
Effective Date 2022-09-29
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 2020-08-14

Description

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

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

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

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
  • Esomeprazole may cause severe skin reactions. Symptoms include:
  • skin reddening
  • blisters
  • rash
  •  
    If an allergic reaction occurs, stop use and seek medical help 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.

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.
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.

Distributed by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

R0922

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.

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).

Active Ingredient (in Each Capsule)

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

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.
Principal Display Panel 42 Capsule Bottle Carton

Compare To

the active ingredient of

Nexium® 24HR

See new warning information

NDC 51660-027-44

Treats Frequent Heartburn

24

HR

Esomeprazole Magnesium

Delayed-Release Capsules

USP, 20 mg* / Acid Reducer

May take 1 to 4 days for full effect

ohm®

42 CAPSULES

Three 14-day courses of treatment

3 x 14 Count Bottles Inside


Structured Label Content

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
Purpose

Acid reducer

Warnings

Allergy alert:

  • Do not use if you are allergic to esomeprazole
  • Esomeprazole may cause severe skin reactions. Symptoms include:
  • skin reddening
  • blisters
  • rash
  •  
    If an allergic reaction occurs, stop use and seek medical help 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.

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.
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.

Distributed by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

R0922

Other Information (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.

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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).

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

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

Ask A Doctor Before Use If You Have: (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 (Ask a doctor or pharmacist before use if you are)
  • taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Principal Display Panel 42 Capsule Bottle Carton (PRINCIPAL DISPLAY PANEL - 42 Capsule Bottle Carton)

Compare To

the active ingredient of

Nexium® 24HR

See new warning information

NDC 51660-027-44

Treats Frequent Heartburn

24

HR

Esomeprazole Magnesium

Delayed-Release Capsules

USP, 20 mg* / Acid Reducer

May take 1 to 4 days for full effect

ohm®

42 CAPSULES

Three 14-day courses of treatment

3 x 14 Count Bottles Inside


Advanced Ingredient Data


Raw Label Data

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