{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "AeroTab Non-Aspirin ACETAMINOPHEN 500MG ES POVIDONE STEARIC ACID STARCH, CORN ACETAMINOPHEN ACETAMINOPHEN SODIUM STARCH GLYCOLATE TYPE A CORN"
      ],
      "active_ingredient": [
        "Acteminophen 500 mg"
      ],
      "purpose": [
        "Pain reliever / fever reducer"
      ],
      "indications_and_usage": [
        "USES temporary relief of minor aches and pains associated with common cold headache toothache muscular aches backache arthritis menstrual cramps temporarily reduces fever"
      ],
      "warnings": [
        "Liver Warning : This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4000 mg of acetaminophen in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Allergy Warning: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away."
      ],
      "do_not_use": [
        "Do not use if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have liver disease."
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin."
      ],
      "stop_use": [
        "Stop use and ask a doctor if symptoms do not improve pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present a rare sensitivity reaction occurs"
      ],
      "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 accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."
      ],
      "dosage_and_administration": [
        "DIRECTIONS take only as directed - see Overdose warning do not take more than 8 tablets in any 24 hour period do not use more than 10 days unless directed to do so by a doctor Adults and children 12 years and over: take 2 tablets every 4 to 6 hours. Children under 12 years of age: do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems."
      ],
      "other_safety_information": [
        "OTHER INFORMATION Tamper evident. Do not use if packet is torn, cut or opened. Store between 20°-25°C (68°-77°F). Read all warnings and directions before use."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid"
      ],
      "package_label_principal_display_panel": [
        "Non Aspirin Tablet AEROTAB Non-Aspirin acetaminophen 500mg Fever reducer Pain Reliever Relieves aches 2 per packet 250"
      ],
      "set_id": "faa3a4ef-3c70-06ca-e053-6394a90a512d",
      "id": "2f179527-4b42-8e0d-e063-6394a90a6257",
      "effective_time": "20250226",
      "version": "2",
      "openfda": {
        "application_number": [
          "M013"
        ],
        "brand_name": [
          "AeroTab Non-Aspirin"
        ],
        "generic_name": [
          "ACETAMINOPHEN 500MG ES"
        ],
        "manufacturer_name": [
          "Aero Healthcare"
        ],
        "product_ndc": [
          "55305-126"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN"
        ],
        "rxcui": [
          "198440"
        ],
        "spl_id": [
          "2f179527-4b42-8e0d-e063-6394a90a6257"
        ],
        "spl_set_id": [
          "faa3a4ef-3c70-06ca-e053-6394a90a512d"
        ],
        "package_ndc": [
          "55305-126-01",
          "55305-126-02",
          "55305-126-04",
          "55305-126-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "9341394017245"
        ],
        "unii": [
          "362O9ITL9D"
        ]
      }
    }
  ]
}