{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Esomeprazole Magnesium esomeprazole ESOMEPRAZOLE ESOMEPRAZOLE ACACIA D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 3 GELATIN, UNSPECIFIED GLYCERYL MONOSTEARATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MEGLUMINE MENTHOL, UNSPECIFIED FORM METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER PEPPERMINT OIL POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 SODIUM LAURYL SULFATE SPEARMINT OIL SUCRALOSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE sealed with green band L898"
      ],
      "active_ingredient": [
        "Active ingredient (in each capsule) Esomeprazole 20 mg (Each delayed-release capsule corresponds to 22 mg esomeprazole magnesium dihydrate)"
      ],
      "purpose": [
        "Purpose Acid reducer"
      ],
      "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"
      ],
      "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. 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 (1-800-222-1222)."
      ],
      "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_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_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are • taking a prescription drug. Acid reducers may interact with certain prescription drugs."
      ],
      "stop_use": [
        "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_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 (1-800-222-1222)."
      ],
      "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."
      ],
      "storage_and_handling": [
        "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_ingredient": [
        "Inactive ingredients acacia, D&C yellow #10, FD&C blue #1, FD&C red #3, gelatin, glyceryl monostearate, hypromellose, magnesium stearate, meglumine, menthol, methacrylic acid and ethyl acrylate copolymer dispersion, natural and artificial cool mint flavor, peppermint oil, pharmaceutical ink, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, spearmint oil, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate"
      ],
      "questions": [
        "Questions or comments? 1-800-719-9260"
      ],
      "package_label_principal_display_panel": [
        "Package/Label Principal Display Panel amazon basics Compare to Nexium® 24 HR active ingredient Flavored Capsules Esomeprazole Magnesium Delayed-Release Capsules, 20 mg Acid Reducer Treats frequent heartburn May take 1 to 4 days for full effect 24 HR Releases a cooling sensation in mouth and throat actual size Cool Mint Flavor 14 CAPSULES One 14-day course of treatment Esomeprazole Magnesium Carton"
      ],
      "set_id": "90d6a679-2968-4b20-a2a6-f3a9908a7e2e",
      "id": "e63fa8bc-cfba-4850-bf49-343492b2f405",
      "effective_time": "20260827",
      "version": "2",
      "openfda": {
        "application_number": [
          "ANDA207193"
        ],
        "brand_name": [
          "Esomeprazole Magnesium"
        ],
        "generic_name": [
          "ESOMEPRAZOLE"
        ],
        "manufacturer_name": [
          "Amazon.com Services LLC"
        ],
        "product_ndc": [
          "72288-563"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ESOMEPRAZOLE"
        ],
        "rxcui": [
          "606726"
        ],
        "spl_id": [
          "e63fa8bc-cfba-4850-bf49-343492b2f405"
        ],
        "spl_set_id": [
          "90d6a679-2968-4b20-a2a6-f3a9908a7e2e"
        ],
        "package_ndc": [
          "72288-563-00",
          "72288-563-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175525",
          "N0000000147",
          "N0000182140"
        ],
        "pharm_class_epc": [
          "Proton Pump Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Proton Pump Inhibitors [MoA]",
          "Cytochrome P450 2C19 Inhibitors [MoA]"
        ],
        "unii": [
          "N3PA6559FT"
        ]
      }
    }
  ]
}