Esomeprazole Magnesium Delayed-release 20 Mg (otc) Capsule, Delayed Release
FDA Label NDC 25000-088

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marksans Pharma Limited for the product Esomeprazole Magnesium Delayed-release 20 Mg (otc) (NDC 25000-088). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(S)

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



Purpose

Purpose 
Acid reducer








Use(S)

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 include:
    • skin reddening 
    • blisters
    • rash

      • If an allergic reaction occurs, stop use and seek medical attention right away.


Do Not Use

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.

Ask A Doctor Before Use If

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

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop Use And Ask 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

Pregnancy/Breastfeeding

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 (1-800-222-1222) 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.

Storage

Other information

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

Inactive Ingredients

 

Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg

 

Inactive ingredients black iron oxide, D&C red 28, eudragit, FD&C blue 1, FD&C red 40, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate.


Esomeprazole Magnesium Delayed-Release Capsules 20 mg (Mini Capsules)

 

Inactive ingredients black iron oxide, corn starch, D&C red 27 aluminum lake, D&C red no. 28, eudragit, FD&C blue 1, FD&C red no. 40, 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.

 

Principal Display Panel

NDC: 25000-088-76

Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg (OTC)

14 count bottle label


Esomeprazole-otc-dr-20mg-14s-bottle-label (Esomeprazole Otc Dr 20mg 14s Bottle Label)

Esomeprazole-otc-dr-20mg-14s-bottle-label (Esomeprazole Otc Dr 20mg 14s Bottle Label)



NDC: 25000-088-76

Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg (OTC)

14 count carton label


Esomeprazole-otc-dr-20mg-14s-carton (Esomeprazole Otc Dr 20mg 14s Carton)

Esomeprazole-otc-dr-20mg-14s-carton (Esomeprazole Otc Dr 20mg 14s Carton)

NDC: 25000-096-76
Esomeprazole Magnesium Delayed-Release Capsules 20 mg (Mini capsules)

14 count bottle label

Esomeprazole-otc-dr-minis-20mg-14s-bottle-label (Esomeprazole Otc Dr Minis 20mg 14s Bottle Label)

Esomeprazole-otc-dr-minis-20mg-14s-bottle-label (Esomeprazole Otc Dr Minis 20mg 14s Bottle Label)

 

NDC: 25000-096-76
Esomeprazole Magnesium Delayed-Release Capsules 20 mg (Mini capsules)

14 count carton label

 

Esomeprazole-otc-dr-minis-20mg-14s-carton (Esomeprazole Otc Dr Minis 20mg 14s Carton)

Esomeprazole-otc-dr-minis-20mg-14s-carton (Esomeprazole Otc Dr Minis 20mg 14s Carton)




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