Esomeprazole Magnesium Capsule, Delayed Release
FDA Label NDC 64980-664

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Esomeprazole Magnesium (NDC 64980-664). 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 description, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Description

Active ingredient (in each capsule)
Purpose
Esomeprazole 20 mg
Acid reducer
(Each delayed-release capsule corresponds to 22.250 mg esomeprazole magnesium trihydrate)

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 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.

          Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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

                  FD&C Blue No.2, gelatin, hypromellose, hydroxy propyl cellulose, magnesium stearate, methacrylic acid & ethyl acrylate copolymer dispersion, mono and di glycerides, pharmaceutical ink, polysorbate 80, sugar spheres, talc, triethyl citrate.

                  Questions or comments?

                  Call 1-844-474-7464

                  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
                  • Manufactured by:

                    Graviti Pharnaceuticals Pvt. Ltd.

                    Telangana-502307, INDIA.

                    M.L.No.: 12/SRD/TS/2017/F/G

                    Revised: 04/2026

                    Distributed by:

                    Rising Pharma Holdings, Inc.

                    East Brunswick, NJ 08816

Package Label.Principal Display Panel

Principal Display Panel - 20 mg Capsules: Container Label

NDC 64980-664-41

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

24 HR

Acid Reducer

Treats Frequent Heartburn

May take 1 to 4 days for full effect

14 Capsules

One 14-day course of treatment

Distributed by: Rising Pharma Holdings, Inc.

Image (B0715b2b 3453 4088 891d 91a1aa22f57d 01)

Image (B0715b2b 3453 4088 891d 91a1aa22f57d 01)

Principal Display Panel - 20 mg Capsules: Carton Label

NDC 64980-664-41

Compare to the active ingredient in Nexium®24HR"

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

24 HR

Acid Reducer

Treats Frequent Heartburn

May take 1 to 4 days for full effect

14 Capsules

One 14-day course of treatment

Distributed by: Rising Pharma Holdings, Inc.

Image (B0715b2b 3453 4088 891d 91a1aa22f57d 02)

Image (B0715b2b 3453 4088 891d 91a1aa22f57d 02)

Img (B0715b2b 3453 4088 891d 91a1aa22f57d 03)

Img (B0715b2b 3453 4088 891d 91a1aa22f57d 03)

Principal Display Panel - 20 mg Capsules: Carton Label

NDC 64980-664-19

Compare to the active ingredient in Nexium® 24HR"

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

24 HR

Acid Reducer

Treats Frequent Heartburn

May take 1 to 4 days for full effect

42 Capsules

Three 14-day courses of treatment

Distributed by: Rising Pharma Holdings, Inc.

Image (B0715b2b 3453 4088 891d 91a1aa22f57d 04)

Image (B0715b2b 3453 4088 891d 91a1aa22f57d 04)

Img (B0715b2b 3453 4088 891d 91a1aa22f57d 05)

Img (B0715b2b 3453 4088 891d 91a1aa22f57d 05)

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