Esomeprazole Magnesium Delayed-release Tablets 20 Mg*

Esomeprazole Magnesium Delayed-release Tablets 20 Mg*
SPL v2
SPL
SPL Set ID 1867185e-9c34-c8cc-e063-6394a90ab3b1
Route
ORAL
Published
Effective Date 2024-07-09
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Esomeprazole (20 mg)
Inactive Ingredients
Silicon Dioxide Crospovidone (120 .mu.m) Hydroxypropyl Cellulose (20000 Wamw) Hypromellose 2910 (3 Mpa.s) Hypromellose 2910 (6 Mpa.s) Low-substituted Hydroxypropyl Cellulose (11% Hydroxypropyl; 130000 Mw) Magnesium Carbonate Magnesium Oxide Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Polysorbate 80 Sodium Lauryl Sulfate Microcrystalline Cellulose 301 Microcrystalline Cellulose 302 Glyceryl Mono And Dipalmitostearate Polyethylene Glycol 6000 Ferric Oxide Red Sodium Stearyl Fumarate Dextrose, Unspecified Form Starch, Corn Sucrose Talc Titanium Dioxide Triethyl Citrate Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance
Imprint: K;12 Shape: oval Color: pink Size: 13 mm Score: 1
Marketing Status
ANDA Active Since 2024-07-04

Description

Active ingredient (in each tablet) *Esomeprazole 20 mg (Each film-coated delayed-release tablet corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Active ingredient (in each tablet) *Esomeprazole 20 mg (Each film-coated delayed-release tablet corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)

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  
Section 50565-1

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)

Warnings

Allergy alert:

■ Do not use if you are allergic to esomeprazole.

■ Esomeprazole may cause severe skin reactions.

   Symptoms may include:

   ■  skin reddening ■  blisters ■  rash

If an allergic reaction occurs, stop use and seek medical help 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 tablet with a glass of water before eating in the morning
  • take every day for 14 days
  • do not take more than 1 tablet a day
  • swallow whole. Do not crush or chew tablets.
  • 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

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20° to 25°C (68° to 77°F)
Drug Facts

Active ingredient (in each tablet)



*Esomeprazole 20 mg

(Each film-coated delayed-release tablet corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)

Inactive Ingredients

colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, hypromellose, low substituted hydroxy propyl cellulose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion (which contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, mono and di-glycerides, polyethylene glycol, polysorbate 80, red iron oxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide, triethyl citrate and yellow iron oxide. 



Questions or comments? call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)



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: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2024 CVS/pharmacy

CVS.com® 1-800-SHOP CVS



Made in India

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.

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.



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.
Package Label Principal Display Panel 20 Mg (14 Tablets)

♥CVSHealth®



NDC 51316-088-01



Treats Frequent Heartburn

May take 1 to 4 days for full effect                            24

Esomeprazole                                                            HOUR

Magnesium

DELAYED-RELEASE TABLETS 20 mg*



Acid reducer



14 TABLETS

One 14-day course of treatment








Structured Label Content

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  
Section 50565-1 (50565-1)

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)

Purpose

Acid reducer

Warnings

Allergy alert:

■ Do not use if you are allergic to esomeprazole.

■ Esomeprazole may cause severe skin reactions.

   Symptoms may include:

   ■  skin reddening ■  blisters ■  rash

If an allergic reaction occurs, stop use and seek medical help 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 tablet with a glass of water before eating in the morning
  • take every day for 14 days
  • do not take more than 1 tablet a day
  • swallow whole. Do not crush or chew tablets.
  • 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

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20° to 25°C (68° to 77°F)
Drug Facts

Active ingredient (in each tablet)



*Esomeprazole 20 mg

(Each film-coated delayed-release tablet corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, hypromellose, low substituted hydroxy propyl cellulose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion (which contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, mono and di-glycerides, polyethylene glycol, polysorbate 80, red iron oxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide, triethyl citrate and yellow iron oxide. 



Questions or comments? call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)



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: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2024 CVS/pharmacy

CVS.com® 1-800-SHOP CVS



Made in India

Do Not Use If You Have: (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.

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, ask a health professional before use.



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.
Package Label Principal Display Panel 20 Mg (14 Tablets) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets))

♥CVSHealth®



NDC 51316-088-01



Treats Frequent Heartburn

May take 1 to 4 days for full effect                            24

Esomeprazole                                                            HOUR

Magnesium

DELAYED-RELEASE TABLETS 20 mg*



Acid reducer



14 TABLETS

One 14-day course of treatment








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