{
  "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": "2026-06-02",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "omeprazole Omeprazole magnesium OMEPRAZOLE MAGNESIUM OMEPRAZOLE FD&C YELLOW NO. 6 FERRIC OXIDE RED GELATIN, UNSPECIFIED GLYCERYL MONOSTEARATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MEGLUMINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 SHELLAC SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE 24S"
      ],
      "active_ingredient": [
        "Active ingredient (in each capsule) Omeprazole delayed-release capsule 20 mg (equivalent to 20.6 mg omeprazole magnesium)"
      ],
      "purpose": [
        "Purpose Acid reducer"
      ],
      "indications_and_usage": [
        "Use • 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 omeprazole. • Omeprazole 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 • for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 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 • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew or crush capsules. 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. Heartburn in children may sometimes be caused by a serious condition."
      ],
      "other_safety_information": [
        "Other information • read the directions and warnings before use • keep the carton. It contains important information. • store at 20-25°C (68-77°F) and protect from moisture • FDA approved dissolution test specifications differ from USP"
      ],
      "inactive_ingredient": [
        "Inactive ingredients FD&C yellow # 6, ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium stearate, meglumine, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, shellac, sodium lauryl sulfate, 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 meijer ® Omeprazole Delayed Release Capsules, 20 mg | Acid Reducer COMPARE TO PRILOSEC OTC ® ACTIVE INGREDIENT 24 HR Treats FREQUENT Heartburn! Mini Capsules 42 CAPSULES THREE 14-DAY COURSES OF TREATMENT MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT See Current Drug Facts Actual Size omeprazole pdp omeprazole dfl"
      ],
      "set_id": "0340ef94-d2b4-47af-a045-d0d031293984",
      "id": "edbe9a75-73ef-4b53-8f08-10e775091e23",
      "effective_time": "20240329",
      "version": "2",
      "openfda": {
        "application_number": [
          "ANDA216096"
        ],
        "brand_name": [
          "omeprazole"
        ],
        "generic_name": [
          "OMEPRAZOLE MAGNESIUM"
        ],
        "manufacturer_name": [
          "Meijer, Inc."
        ],
        "product_ndc": [
          "79481-0281"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "OMEPRAZOLE MAGNESIUM"
        ],
        "rxcui": [
          "198051"
        ],
        "spl_id": [
          "edbe9a75-73ef-4b53-8f08-10e775091e23"
        ],
        "spl_set_id": [
          "0340ef94-d2b4-47af-a045-d0d031293984"
        ],
        "package_ndc": [
          "79481-0281-0",
          "79481-0281-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "426QFE7XLK"
        ]
      }
    }
  ]
}