{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Feverall Childrens Acetaminophen ACETAMINOPHEN ACETAMINOPHEN GLYCERYL MONOSTEARATE HYDROGENATED PALM KERNEL OIL PEG-100 STEARATE POLYSORBATE 80"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Dist. by: Ohm Laboratories, Inc. New Brunswick, NJ 08901"
      ],
      "active_ingredient": [
        "Active ingredient (in each rectal suppository) Acetaminophen, USP 120 mg"
      ],
      "purpose": [
        "Purposes Pain reliever/fever reducer"
      ],
      "indications_and_usage": [
        "Uses temporarily reduces fever relieves minor aches, pains, and headache"
      ],
      "warnings": [
        "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Allergy alert: 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. For rectal use only. 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 a doctor before use if the child has liver disease. the child is taking the blood thinning drug warfarin. Stop use and ask a doctor if fever lasts more than 3 days (72 hours), or recurs. pain lasts more than 5 days or gets worse. new symptoms occur. redness or swelling is present in the painful area. These may be signs of a serious condition. Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms."
      ],
      "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 the child has liver disease. the child is taking the blood thinning drug warfarin."
      ],
      "stop_use": [
        "Stop use and ask a doctor if fever lasts more than 3 days (72 hours), or recurs. pain lasts more than 5 days or gets worse. new symptoms occur. redness or swelling is present in the painful area. These may be signs of a serious condition."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms."
      ],
      "dosage_and_administration": [
        "Directions this product does not contain directions or warnings for adult use do not use more than directed remove wrapper carefully insert suppository well up into the rectum Dosing Chart Age Dose under 3 years Do not use unless directed by a doctor 3 to 6 years Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)"
      ],
      "dosage_and_administration_table": [
        "<table width=\"50%\"><caption>Dosing Chart</caption><col width=\"40%\" align=\"left\" valign=\"top\"/><col width=\"60%\" align=\"left\" valign=\"top\"/><thead><tr><th styleCode=\"Lrule Rrule\">Age</th><th styleCode=\"Rrule\">Dose</th></tr></thead><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">under 3 years</td><td styleCode=\"Rrule\">Do not use unless directed by a doctor</td></tr><tr><td styleCode=\"Lrule Rrule\">3 to 6 years</td><td styleCode=\"Rrule\">Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)</td></tr></tbody></table>"
      ],
      "storage_and_handling": [
        "Other information store at 2°-27°C (35°-80°F) do not use if imprinted suppository wrapper is opened or damaged"
      ],
      "inactive_ingredient": [
        "Inactive ingredients glycerol monostearate, hydrogenated vegetable oil, polyoxyethylene stearate, polysorbate 80"
      ],
      "questions": [
        "Questions? call 1-866-923-4914"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 120 mg Suppository Blister Pack Carton NDC 51672-2115-2 FeverAll ® Children's ACETAMINOPHEN SUPPOSITORIES Carton"
      ],
      "set_id": "861e2987-5473-45b0-b2a6-f980a9b0e809",
      "id": "59cc44c6-9464-1e04-e063-6394a90a7466",
      "effective_time": "20260824",
      "version": "8",
      "openfda": {
        "application_number": [
          "NDA018337"
        ],
        "brand_name": [
          "Feverall Childrens"
        ],
        "generic_name": [
          "ACETAMINOPHEN"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "51672-2115"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "RECTAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN"
        ],
        "rxcui": [
          "198434",
          "209353"
        ],
        "spl_id": [
          "59cc44c6-9464-1e04-e063-6394a90a7466"
        ],
        "spl_set_id": [
          "861e2987-5473-45b0-b2a6-f980a9b0e809"
        ],
        "package_ndc": [
          "51672-2115-0",
          "51672-2115-2",
          "51672-2115-4"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "362O9ITL9D"
        ]
      }
    }
  ]
}