{
  "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": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Ibuprofen Ibuprofen capsule GELATIN POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM HYDROXIDE WATER FD&C BLUE NO. 1 SORBITAN SORBITOL IBUPROFEN IBUPROFEN IB4"
      ],
      "active_ingredient": [
        "Active ingredient (in each capsule) Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug"
      ],
      "purpose": [
        "Purpose Pain reliever/Fever reducer"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever"
      ],
      "warnings": [
        "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be be fatal. The risk is higher if you use more than directed or for longer than directed."
      ],
      "do_not_use": [
        "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery"
      ],
      "ask_doctor": [
        "Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug"
      ],
      "when_using": [
        "When using this product take with food or milk if stomach upset occurs"
      ],
      "stop_use": [
        "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause delivery problems in the unborn child or complications during delivery."
      ],
      "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."
      ],
      "dosage_and_administration": [
        "Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules in 24 hours, unless directed by a doctor children under 12 years: ask a doctor"
      ],
      "storage_and_handling": [
        "Other information each capsule contains: potassium 20 mg read all warnings and directions before use. Keep carton. store at 20° to 25°C (68° to 77°F) avoid excessive heat above 40°C (104°F). Protect from light."
      ],
      "inactive_ingredient": [
        "Inactive ingredients FD&C Blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol"
      ],
      "questions": [
        "Questions or comments? call toll free 1-888-235-2466"
      ],
      "spl_unclassified_section": [
        "READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING. †This product is not manufactured or distributed by the owners of Advil ® LIQUI-GELS ® . DISTRIBUTED BY PUBLIX SUPER MARKETS, INC., 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811 1-888-267-3037 publix.com PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUR MONEY BACK Publix ® L0000809 R0324 Lot No: Exp. Date:"
      ],
      "package_label_principal_display_panel": [
        "80's carton NDC 56062-560-78 Ibuprofen Capsules, 200 mg • Pain reliever/fever reducer (NSAID) • Mini capsules • Smaller capsule, same strength ACTUAL SIZE 80 Softgels** **Liquid–filled capsules Compare to the active ingredient in Advil® LIQUI-GELS®† carton"
      ],
      "set_id": "10a6eba7-e400-ce97-e063-6294a90af3bd",
      "id": "1ab533b4-6f4b-58fa-e063-6294a90a5c25",
      "effective_time": "20240612",
      "version": "2",
      "openfda": {
        "application_number": [
          "ANDA078682"
        ],
        "brand_name": [
          "Ibuprofen"
        ],
        "generic_name": [
          "IBUPROFEN CAPSULE"
        ],
        "manufacturer_name": [
          "PUBLIX SUPER MARKETS INC"
        ],
        "product_ndc": [
          "56062-560"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IBUPROFEN"
        ],
        "rxcui": [
          "310964"
        ],
        "spl_id": [
          "1ab533b4-6f4b-58fa-e063-6294a90a5c25"
        ],
        "spl_set_id": [
          "10a6eba7-e400-ce97-e063-6294a90af3bd"
        ],
        "package_ndc": [
          "56062-560-11",
          "56062-560-78",
          "56062-560-83"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000160",
          "M0001335",
          "N0000175722"
        ],
        "pharm_class_moa": [
          "Cyclooxygenase Inhibitors [MoA]"
        ],
        "pharm_class_cs": [
          "Anti-Inflammatory Agents, Non-Steroidal [CS]"
        ],
        "pharm_class_epc": [
          "Nonsteroidal Anti-inflammatory Drug [EPC]"
        ],
        "unii": [
          "WK2XYI10QM"
        ]
      }
    }
  ]
}