Albertsons Esomeprazole Magnesium Delayed-release 20 Mg Mini

Albertsons Esomeprazole Magnesium Delayed-release 20 Mg Mini
SPL v2
SPL
SPL Set ID f2c06861-0324-93ed-e053-2995a90a5902
Route
ORAL
Published
Effective Date 2024-04-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Esomeprazole (20 mg)
Inactive Ingredients
Starch, Corn Fd&c Blue No. 1 Potassium Hydroxide Talc Shellac Dimethicone Sucrose Triethyl Citrate Ferrosoferric Oxide Methacrylic Acid And Ethyl Acrylate Copolymer Glyceryl Monostearate Hydroxypropyl Cellulose, Unspecified Fd&c Red No. 3 Titanium Dioxide D&c Red No. 27 Aluminum Lake Magnesium Stearate Ferric Oxide Yellow Gelatin Hypromellose, Unspecified Sodium Lauryl Sulfate Polysorbate 80

Identifiers & Packaging

Pill Appearance
Imprint: 112 Shape: capsule Color: yellow Size: 11 mm Score: 1
Marketing Status
ANDA Active Since 2024-04-29

Description

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


Medication Information

Warnings and Precautions

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.

Indications and Usage

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
Dosage and Administration

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.

Description

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

Section 44425-7

Other information

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20-25°C (68-77°F)
Section 50565-1

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

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 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

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

Inactive ingredients black iron oxide, corn starch, D&C red 27 aluminum lake, eudragit, FD&C blue 1, FD&C red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triethyl citrate

Section 51945-4

Section 53413-1

Questions or comments? Call 1-877-290-4008

Section 53414-9

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

Section 55105-1

Purpose

Acid reducer

Section 55106-9

Active ingredient (in each capsule)

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 44425-7 (44425-7)

Other information

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20-25°C (68-77°F)
Section 50565-1 (50565-1)

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

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 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)

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)

Inactive ingredients black iron oxide, corn starch, D&C red 27 aluminum lake, eudragit, FD&C blue 1, FD&C red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triethyl citrate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-877-290-4008

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Acid reducer

Section 55106-9 (55106-9)

Active ingredient (in each capsule)

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)


Advanced Ingredient Data


Raw Label Data

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