{
  "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": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "MEDIQUE APAP EXTRA STRENGTH acetaminophen tablet, film coated MEDIQUE APAP EXTRA STRENGTH acetaminophen tablet, film coated POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO HYPROMELLOSES STARCH, CORN ACETAMINOPHEN ACETAMINOPHEN STEARIC ACID TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED AZ;235"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "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/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 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 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.",
        "QUESTIONS Questions or comments? 1-800-634-7680"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENT Active ingredient (in each tablet) Acetaminophen 500 mg"
      ],
      "purpose": [
        "PURPOSE Purpose Pain reliever/fever reducer"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis backahe 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."
      ],
      "dosage_and_administration": [
        "Directions do not use more than directed (see overdose warning) ​ Adults and children: (12 years and over) take 2 tablets every 6 hours while symptoms last. do not take more than 6 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_safety_information": [
        "Other information store at room temperature 59º-86ºF (15º-30ºC) tamper-evident sealed packets do not use any opened or torn packets"
      ],
      "inactive_ingredient": [
        "Inactive ingredients corn starch, hypromellose*, polyethylene glycol*, povidone, pregelatinized corn starch*, sodium starch glycolate*, stearic acid*, titanium dioxide* *may contain"
      ],
      "keep_out_of_reach_of_children": [
        "KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN"
      ],
      "package_label_principal_display_panel": [
        "SERIALIZED LABEL"
      ],
      "set_id": "0dfa3df0-db88-be14-e063-6294a90a6a9d",
      "id": "0dfa3df0-db89-be14-e063-6294a90a6a9d",
      "effective_time": "20240102",
      "version": "1",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "MEDIQUE APAP EXTRA STRENGTH acetaminophen tablet, film coated"
        ],
        "generic_name": [
          "MEDIQUE APAP EXTRA STRENGTH ACETAMINOPHEN TABLET, FILM COATED"
        ],
        "manufacturer_name": [
          "HF Acquisition Co LLC, DBA HealthFirst"
        ],
        "product_ndc": [
          "51662-1274"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN"
        ],
        "rxcui": [
          "198440"
        ],
        "spl_id": [
          "0dfa3df0-db89-be14-e063-6294a90a6a9d"
        ],
        "spl_set_id": [
          "0dfa3df0-db88-be14-e063-6294a90a6a9d"
        ],
        "package_ndc": [
          "51662-1274-2"
        ],
        "original_packager_product_ndc": [
          "47682-175"
        ],
        "unii": [
          "362O9ITL9D"
        ]
      }
    }
  ]
}