{
  "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": "2026-08-11",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Esomeprazole Magnesium esomeprazole magnesium capsule, delayed release ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE IRON OXIDES FD&C BLUE NO. 1 FD&C BLUE NO. 2 GELATIN GLYCERYL MONOSTEARATE HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POTASSIUM HYDROXIDE POLYSORBATE 80 PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE AMMONIA SUCROSE STARCH, CORN TALC TITANIUM DIOXIDE TRIETHYL CITRATE DIMETHICONE, UNSPECIFIED blue opaque body white opaque cap E4;H"
      ],
      "active_ingredient": [
        "Active ingredient(s) Esomeprazole 20 mg (*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP)."
      ],
      "purpose": [
        "Purpose Acid reducer"
      ],
      "indications_and_usage": [
        "Use(s) 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 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 breastfeeding, 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 (1-800-222-1222) right away."
      ],
      "do_not_use": [
        "Do not use 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 breastfeeding, 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."
      ],
      "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."
      ],
      "spl_unclassified_section": [
        "Other information read the directions and warnings before use • keep the carton. It contains important information. • store at 20-25°C (68-77°F) 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."
      ],
      "inactive_ingredient": [
        "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."
      ],
      "questions": [
        "Questions/Comments Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Esomeprazole Magnesium Label Esomeprazole Magnesium 14ct Esomeprazole Magnesium 42ct Esomeprazole Magnesium Esomeprazole Magnesium 14ct Esomeprazole Magnesium 42ct"
      ],
      "set_id": "42fa9084-89db-45ad-8212-4eeb53659a98",
      "id": "8544b126-0544-4f7c-a5f6-3cc1b136505d",
      "effective_time": "20250130",
      "version": "2",
      "openfda": {
        "application_number": [
          "ANDA212507"
        ],
        "brand_name": [
          "Esomeprazole Magnesium"
        ],
        "generic_name": [
          "ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE"
        ],
        "manufacturer_name": [
          "Allegiant Health"
        ],
        "product_ndc": [
          "69168-472"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ESOMEPRAZOLE MAGNESIUM"
        ],
        "rxcui": [
          "606726"
        ],
        "spl_id": [
          "8544b126-0544-4f7c-a5f6-3cc1b136505d"
        ],
        "spl_set_id": [
          "42fa9084-89db-45ad-8212-4eeb53659a98"
        ],
        "package_ndc": [
          "69168-472-14",
          "69168-472-61",
          "69168-472-42",
          "69168-472-62",
          "69168-472-15"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0369168464421"
        ],
        "unii": [
          "R6DXU4WAY9"
        ]
      }
    }
  ]
}