{
  "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": [
        "Aspirin Enteric Coated Aspirin 81 mg ASPIRIN ASPIRIN SILICON DIOXIDE STARCH, CORN CROSPOVIDONE D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED METHACRYLIC ACID MICROCRYSTALLINE CELLULOSE STEARIC ACID TALC TITANIUM DIOXIDE TRIETHYL CITRATE A"
      ],
      "active_ingredient": [
        "Active ingredient(s) Aspirin 81mg (NSAID)* *nonsteroidal anti-inflammatory drug"
      ],
      "purpose": [
        "Purpose Pain reliever"
      ],
      "indications_and_usage": [
        "Use(s) for the temporary relief of minor aches and pain or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief."
      ],
      "warnings": [
        "Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert : Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock 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 non prescription 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 Do not use if you are allergic to aspirin or any other pain reliever/fever reducer if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma Ask a doctor or pharmacist before use if taking a prescription drug for anticoagulation (thinning the blood) diabetes gout arthritis Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. 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 pain gets worse or lasts more than10 days redness or swelling is present new symptoms occur ringing in the ears or loss of hearing occurs You may report side effects to 1-888-952-0050 Pregnancy/Breastfeeding If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless specifically 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 In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "do_not_use": [
        "Do not use if you are allergic to aspirin or any other pain reliever/fever reducer if you have ever had an allergic reaction to this product or any of its ingredients"
      ],
      "ask_doctor": [
        "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if taking a prescription drug for anticoagulation (thinning the blood) diabetes gout arthritis"
      ],
      "stop_use": [
        "Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. 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 pain gets worse or lasts more than10 days redness or swelling is present new symptoms occur ringing in the ears or loss of hearing occurs You may report side effects to 1-888-952-0050"
      ],
      "pregnancy_or_breast_feeding": [
        "Pregnancy/Breastfeeding If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless specifically 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "Directions drink a full glass of water with each dose adults and children 12 years and over : take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor"
      ],
      "spl_unclassified_section": [
        "Other information store at room temperature 20°– 25°C (68°–77°F) do not use if imprinted seal under safety cap is broken or missing"
      ],
      "inactive_ingredient": [
        "Inactive ingredients ccolloidal silicon dioxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl citrate."
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Aspirin 81mg EC Aspirin 81mg EC"
      ],
      "set_id": "04017bc9-602a-4204-96a9-b7f9713155f6",
      "id": "c8032d71-2485-4ab4-a20f-153fc3dc6281",
      "effective_time": "20230131",
      "version": "4",
      "openfda": {
        "application_number": [
          "M013"
        ],
        "brand_name": [
          "Aspirin Enteric Coated"
        ],
        "generic_name": [
          "ASPIRIN 81 MG"
        ],
        "manufacturer_name": [
          "Lodaat LLC"
        ],
        "product_ndc": [
          "83139-372"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ASPIRIN"
        ],
        "rxcui": [
          "308416"
        ],
        "spl_id": [
          "c8032d71-2485-4ab4-a20f-153fc3dc6281"
        ],
        "spl_set_id": [
          "04017bc9-602a-4204-96a9-b7f9713155f6"
        ],
        "package_ndc": [
          "83139-372-60"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0045635945241"
        ],
        "nui": [
          "N0000000160",
          "N0000008836",
          "M0001335",
          "N0000175722",
          "N0000175578",
          "N0000008832"
        ],
        "pharm_class_moa": [
          "Cyclooxygenase Inhibitors [MoA]"
        ],
        "pharm_class_pe": [
          "Decreased Prostaglandin Production [PE]",
          "Decreased Platelet Aggregation [PE]"
        ],
        "pharm_class_cs": [
          "Anti-Inflammatory Agents, Non-Steroidal [CS]"
        ],
        "pharm_class_epc": [
          "Nonsteroidal Anti-inflammatory Drug [EPC]",
          "Platelet Aggregation Inhibitor [EPC]"
        ],
        "unii": [
          "R16CO5Y76E"
        ]
      }
    }
  ]
}