Esomeprazole Magnesium Delayed-release Capsules Usp, 20 Mg (otc)

Esomeprazole Magnesium Delayed-release Capsules Usp, 20 Mg (otc)
SPL v5
SPL
SPL Set ID d2554c3d-eb0b-4bf8-aebc-18be7b195c8e
Route
ORAL
Published
Effective Date 2024-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Esomeprazole (20 mg)
Inactive Ingredients
Talc Triethyl Citrate Ferrosoferric Oxide Fd&c Blue No. 1 Fd&c Blue No. 2 Gelatin Glyceryl Monostearate Magnesium Stearate Potassium Hydroxide Polysorbate 80 Propylene Glycol Shellac Sodium Lauryl Sulfate Sucrose Hydroxypropyl Cellulose Ammonia Starch, Corn Titanium Dioxide Dimethicone Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Hypromellose 2910 (5 Mpa.s)

Identifiers & Packaging

Pill Appearance
Imprint: H;E4 Shape: capsule Color: white Color: blue Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2020-06-02

Description

Esomeprazole 20 mg (*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP).

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Esomeprazole 20 mg (*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate 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.
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 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.

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)
Inactive Ingredients

Black iron oxide, FD&C Blue No. 1, FD&C Blue No. 2, gelatin, glyceryl monostearate, hydroxy propyl cellulose, hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, potassium hydroxide, polysorbate 80, propylene glycol, shellac, simethicone, sodium lauryl sulfate, strong ammonia solution, sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.

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.

Questions Or Comments?

call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418.



Distributed by:

Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA.

Principal Display Panel

Esomeprazole Magnesium Delayed-Release Capsules, USP, 20 mg - Carton (Hetero)

Esomeprazole Magnesium Delayed-Release Capsules, USP, 20 mg - Carton (Annora)

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.

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
Active Ingredient (in Each Capsule)

Esomeprazole 20 mg

(*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP).

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.





Structured Label Content

Uses (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.
Purpose (PURPOSE)

Acid reducer

Warnings (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 (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.

Other Information (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)
Inactive Ingredients (INACTIVE INGREDIENTS)

Black iron oxide, FD&C Blue No. 1, FD&C Blue No. 2, gelatin, glyceryl monostearate, hydroxy propyl cellulose, hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, potassium hydroxide, polysorbate 80, propylene glycol, shellac, simethicone, sodium lauryl sulfate, strong ammonia solution, sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.

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.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418.



Distributed by:

Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Esomeprazole Magnesium Delayed-Release Capsules, USP, 20 mg - Carton (Hetero)

Esomeprazole Magnesium Delayed-Release Capsules, USP, 20 mg - Carton (Annora)

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.

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
Active Ingredient (in Each Capsule) (ACTIVE INGREDIENT (in each capsule))

Esomeprazole 20 mg

(*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP).

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.





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Raw Label Data

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