Esomeprazole Magnesium Capsule, Delayed Release
FDA Label NDC 72657-127

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Glenmark Therapeutics Inc., Usa for the product Esomeprazole Magnesium (NDC 72657-127). 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, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22.250 mg esomeprazole magnesium trihydrate)

Purpose

Acid reducer

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.

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.

    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 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.

          • 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.

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).

          • Questions or comments?

          Call toll-free weekdays 9 AM to 6 PM EST at 1-888-721-7115.

          Product of India

          Additional Information

          Do Not Use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" or Blue band around the center of each capsule is broken or missing.

          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:

            Glenmark Therapeutics Inc., USA

            Elmwood Park, NJ 07407

            Product of India

            07/25

Inactive Ingredients

FD&C Blue No. 2, gelatin, hydroxy propyl cellulose, hypromellose, magnesium stearate, methacrylic

acid and ethyl acrylate copolymer dispersion, mono-and di-glycerides, pharmaceutical ink, polysorbate 80, sugar spheres, talc, triethyl citrate.

Package/Label Principal Display Panel

Principal Display Panel - 20 mg Capsules: Container Label

NDC 72657-127-14

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

Acid Reducer

Treats Frequent Heartburn

May take 1 to 4 days for full effect

24 HOURS

14 Capsules

One 14-day course of treatment

Product of India

Label (Label)

Label (Label)

Principal Display Panel - 42 Capsules Carton label

NDC 73657-127-42

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

Acid Reducer

Treats Frequent Heartburn

May take 1 to 4 days for full effect

24 HOURS

42 Capsules

Three 14-day courses of treatment

Product of India

Carton (Carton)

Carton (Carton)

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