{
  "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": "2026-06-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "PROPRINAL Ibuprofen Capsules 200 mg WATER SHELLAC FD&C GREEN NO. 3 AMMONIA GELATIN, UNSPECIFIED FERROSOFERRIC OXIDE POLYETHYLENE GLYCOL, UNSPECIFIED IBUPROFEN IBUPROFEN MEDIUM-CHAIN TRIGLYCERIDES PROPYLENE GLYCOL POTASSIUM HYDROXIDE SORBITAN MONOOLEATE SORBITOL 133"
      ],
      "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 muscular aches backache minor arthritis pain the common cold toothache menstrual cramps Temporarily reduces fever"
      ],
      "warnings": [
        "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives blisters shock facial swelling asthma (wheezing) rash skin reddening 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 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 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 take aspirin for heart attack or stroke (ibuprofen may decrease this benefit of aspirin) take any other drug"
      ],
      "when_using": [
        "When using this produc take with food or milk if stomach upset occurs"
      ],
      "stop_use": [
        "Stop use and ask a doctor if an allergic reaction occurs, seek medical help right away fever worsens or lasts more than 3 days pain worsens or lasts more than 10 days you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better new symptoms occur redness or swelling is present you have symptoms of heart problems or stroke: chest pain, trouble breathing, weakness in one part or side of the body, slurred speech, or leg swelling"
      ],
      "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 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 (1-800-222-1222)."
      ],
      "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 take more than 6 capsules in 24 hours, unless directed by a doctor children under 12 years of age : ask a doctor"
      ],
      "other_safety_information": [
        "OTHER INFORMATION Other information each capsule contains: potassium 20 mg caplets enclosed in a sealed packet do not use if packet is torn, cut or open store at 59° to 86°F (15°-30°C) avoid excessive heat and humidity"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Ammonium hydroxide, FD&C green #3, gelatin, iron oxide black, medium chain triglycerides, polyethylene glycol, propylene glycol, potassium hydroxide, purified water, shellac, sorbitan monooleate, sorbitol sorbitan"
      ],
      "how_supplied": [
        "HOW SUPPLIED Product: 50090-3507 NDC: 50090-3507-0 2 CAPSULE, LIQUID FILLED in a PACKET / 300 in a BOX"
      ],
      "package_label_principal_display_panel": [
        "IBUPROFEN CAPSULES Label Image"
      ],
      "set_id": "4723dd14-5d20-4a9a-b127-4237d5db5956",
      "id": "4ed90335-efbd-499b-88ca-a39348b8e13d",
      "effective_time": "20240129",
      "version": "1",
      "openfda": {
        "application_number": [
          "ANDA079205"
        ],
        "brand_name": [
          "PROPRINAL"
        ],
        "generic_name": [
          "IBUPROFEN CAPSULES 200 MG"
        ],
        "manufacturer_name": [
          "A-S Medication Solutions"
        ],
        "product_ndc": [
          "50090-3507"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IBUPROFEN"
        ],
        "rxcui": [
          "310964",
          "2673691"
        ],
        "spl_id": [
          "4ed90335-efbd-499b-88ca-a39348b8e13d"
        ],
        "spl_set_id": [
          "4723dd14-5d20-4a9a-b127-4237d5db5956"
        ],
        "package_ndc": [
          "50090-3507-0"
        ],
        "original_packager_product_ndc": [
          "50332-0130"
        ],
        "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"
        ]
      }
    }
  ]
}