Esomeprazole Delayed Release Orally Disintegrating Tablets, 20 Mg

Esomeprazole Delayed Release Orally Disintegrating Tablets, 20 Mg
SPL v3
SPL
SPL Set ID 3922a971-b371-4159-8c34-369798809965
Route
ORAL
Published
Effective Date 2025-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Esomeprazole (20 mg)
Inactive Ingredients
Acetone Alcohol Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate Copolymer Ascorbic Acid Benzyl Alcohol Cetyl Alcohol Crospovidone Fd&c Blue No. 1--aluminum Lake Fd&c Blue No. 2--aluminum Lake Hypromellose 2910 (5 Mpa.s) Hypromellose Phthalate (31% Phthalate, 170 Cst) Isopropyl Alcohol Mannitol Microcrystalline Cellulose Modified Corn Starch (1-octenyl Succinic Anhydride) Polysorbate 80 Silicon Dioxide Sodium Stearate Sodium Stearyl Fumarate Sorbitol Starch, Corn Sucralose Sucrose Talc Titanium Dioxide Triacetin Triethyl Citrate

Identifiers & Packaging

Marketing Status
NDA Active Since 2024-04-12

Description

Active ingredient (in each tablet) Esomeprazole 20 mg (Each delayed-release tablet corresponds to 22.3 mg esomeprazole magnesium trihydrate) 


Medication Information

Warnings and Precautions

Allergy alert: Do not use if you are allergic to esomeprazole

Indications and Usage
  • 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
Dosage and Administration

14-Day Course of Treatment

  • take 1 tablet before eating in the morning
  • do not crush or chew tablets
  • place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
  • take every day for 14 days
  • do not take more than 1 tablet a day
  • do not use for more than 14 days unless directed by your doctor
  • do not take this medicine with alcohol
Description

Active ingredient (in each tablet) Esomeprazole 20 mg (Each delayed-release tablet corresponds to 22.3 mg esomeprazole magnesium trihydrate) 

Section 34076-0

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.
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).

Section 50566-9
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 
Section 50567-7
  •  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 50568-5
Ask a doctor or pharmacist before use if you are

  • taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Section 50569-3

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
Section 50570-1
  • 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.

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 51727-6

acetone, alcohol, amino methacrylate copolymer, ascorbic acid, benzyl alcohol, cetyl alcohol, colloidal silicon dioxide, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, flavor, hypromellose, hypromellose phthalate, isopropyl alcohol, mannitol, microcrystalline cellulose, modified starch, polysorbate 80, pregelatinized starch, silicon dioxide, sodium stearate, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triacetin, triethyl citrate

Section 51945-4

NDC 64239-112-02

MELTechTM

Melts in Your Mouth

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts  in your mouth

Dissolves without water

14 TABLETS

One 14-day course of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size

Section 53413-1

Weekdays XXX AM to XXX PM EST

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Acid reducer 

Section 55106-9

Active ingredient (in each tablet)

Esomeprazole 20 mg

(Each delayed-release tablet corresponds to 22.3 mg

esomeprazole magnesium trihydrate) 

Section 60561-8

Other information

  • read the directions and warnings before use
  • keep the carton. It contains important information
  • store at 20-25°C (68-77°F); keep product out of high heat and moisture
  • store in the original package
Section 88436-1
  • 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.

Structured Label Content

Indications and Usage (34067-9)
  • 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
Dosage and Administration (34068-7)

14-Day Course of Treatment

  • take 1 tablet before eating in the morning
  • do not crush or chew tablets
  • place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
  • take every day for 14 days
  • do not take more than 1 tablet a day
  • do not use for more than 14 days unless directed by your doctor
  • do not take this medicine with alcohol
Warnings and Precautions (34071-1)

Allergy alert: Do not use if you are allergic to esomeprazole

Section 34076-0 (34076-0)

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.
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).

Section 50566-9 (50566-9)
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 
Section 50567-7 (50567-7)
  •  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 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are

  • taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)
  • 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.

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 51727-6 (51727-6)

acetone, alcohol, amino methacrylate copolymer, ascorbic acid, benzyl alcohol, cetyl alcohol, colloidal silicon dioxide, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, flavor, hypromellose, hypromellose phthalate, isopropyl alcohol, mannitol, microcrystalline cellulose, modified starch, polysorbate 80, pregelatinized starch, silicon dioxide, sodium stearate, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triacetin, triethyl citrate

Section 51945-4 (51945-4)

NDC 64239-112-02

MELTechTM

Melts in Your Mouth

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts  in your mouth

Dissolves without water

14 TABLETS

One 14-day course of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size

Section 53413-1 (53413-1)

Weekdays XXX AM to XXX PM EST

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Acid reducer 

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Esomeprazole 20 mg

(Each delayed-release tablet corresponds to 22.3 mg

esomeprazole magnesium trihydrate) 

Section 60561-8 (60561-8)

Other information

  • read the directions and warnings before use
  • keep the carton. It contains important information
  • store at 20-25°C (68-77°F); keep product out of high heat and moisture
  • store in the original package
Section 88436-1 (88436-1)
  • 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.

Advanced Ingredient Data


Raw Label Data

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