{
  "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": "2026-06-10",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "MEDIQUE APAP acetaminophen MEDIQUE APAP acetaminophen HYPROMELLOSE, UNSPECIFIED STARCH, CORN POVIDONE K30 STEARIC ACID SODIUM STARCH GLYCOLATE TYPE A POTATO ACETAMINOPHEN ACETAMINOPHEN POLYETHYLENE GLYCOL, UNSPECIFIED G323"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient (in each tablet) Acetaminophen 325 mg"
      ],
      "purpose": [
        "Pain reliever/fever reducer"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves minor aches and pains due to: headache muscular aches minor arthritis pain backache the common cold toothache premenstrual and menstrual cramps temporarily reduces fever"
      ],
      "warnings": [
        "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop using and ask a doctor if pain gets worse and lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."
      ],
      "do_not_use": [
        "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product"
      ],
      "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 using and ask a doctor if pain gets worse and lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children."
      ],
      "overdosage": [
        "Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 do not use more than directed (see overdose warning) ​Adults and children: (12 years and over) take 2 tablets every 4 to 6 hours while symptoms last. do not take more than 10 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor Children under 12 years: ask a doctor Other information store at room temperature 59°-86°F (15°-30°C) tamper-evident sealed packets do not use any opened or torn packets"
      ],
      "inactive_ingredient": [
        "Inactive ingredients corn starch*, hypromellose, polyethylene glycol, povidone (K-30)*, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide* May contain*"
      ],
      "how_supplied": [
        "Pain Reliever/Fever Reducer • Acetaminophen 325 mg in a pouch NDC (51662-1273-2)"
      ],
      "package_label_principal_display_panel": [
        "Label"
      ],
      "set_id": "3ba5c802-fe5a-e42a-e063-6394a90ae67e",
      "id": "3ba5c802-fe5b-e42a-e063-6394a90ae67e",
      "effective_time": "20250805",
      "version": "1",
      "openfda": {
        "application_number": [
          "M013"
        ],
        "brand_name": [
          "MEDIQUE APAP acetaminophen"
        ],
        "generic_name": [
          "MEDIQUE APAP ACETAMINOPHEN"
        ],
        "manufacturer_name": [
          "HF Acquisition Co LLC, DBA HealthFirst"
        ],
        "product_ndc": [
          "51662-1273"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN"
        ],
        "rxcui": [
          "313782"
        ],
        "spl_id": [
          "3ba5c802-fe5b-e42a-e063-6394a90ae67e"
        ],
        "spl_set_id": [
          "3ba5c802-fe5a-e42a-e063-6394a90ae67e"
        ],
        "package_ndc": [
          "51662-1273-2"
        ],
        "original_packager_product_ndc": [
          "47682-057"
        ],
        "unii": [
          "362O9ITL9D"
        ]
      }
    }
  ]
}