{
  "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": [
        "Acetaminophen Extra Strength Acetaminophen 500mg/15mL WATER SUCRALOSE ANHYDROUS CITRIC ACID POLYETHYLENE GLYCOL 350 PROPYLENE GLYCOL METHYLPARABEN PROPYLPARABEN SODIUM CITRATE ACETAMINOPHEN ACETAMINOPHEN"
      ],
      "active_ingredient": [
        "Active ingredient (in each 15 mL-teaspoonful) Acetaminophen 500 mg"
      ],
      "purpose": [
        "Purpose Pain reliever/fever reducer"
      ],
      "indications_and_usage": [
        "Uses Temporarily relieves minor aches and pains temporarily reduces fever"
      ],
      "warnings": [
        "Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoonfuls in 24 hours. Severe liver damage may occur if:you take more than 8 tablespoonfuls (4,000mg of acetaminophen) in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks everyday while using the 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": [
        "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 your child has liver disease"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor before use if you have taking the blood thinning drug warfarin."
      ],
      "when_using": [
        "When using this product do not exceed recommended dose"
      ],
      "stop_use": [
        "Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts 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. In case of overdose, get medical help or conbtact a Poison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding ask a health professional before use"
      ],
      "dosage_and_administration": [
        "Directions do not take more than directed Age DOSE Adults and children 12 years of age and older Take 1 to 2 tablespoonfuls every 4 to 6 hours as needed, not more than 6 Tablespoonfuls in 24 hours Children under 12 years Do not use"
      ],
      "dosage_and_administration_table": [
        "<table border=\"2\" width=\"100%\"><tbody><tr><td><content styleCode=\"bold\">Age</content></td><td><content styleCode=\"bold\">DOSE</content></td></tr><tr><td>Adults and children 12 years of age and older</td><td>Take 1 to 2 tablespoonfuls every 4 to 6 hours as needed, not more than 6 Tablespoonfuls in 24 hours</td></tr><tr><td>Children under 12 years</td><td>Do not use</td></tr></tbody></table>"
      ],
      "other_safety_information": [
        "Other information store at room temperature between 15-30°C (59-86°F) protect from freezing protect from light TAMPER EVIDENT do not use if foil seal over bottle opening is torn, broken or missing"
      ],
      "inactive_ingredient": [
        "Inactive Ingredient artificial and natural cherry flavor, citric acid, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose"
      ],
      "questions": [
        "Question or Comments? call 305-592-9216 or info@aldamapharm.com"
      ],
      "package_label_principal_display_panel": [
        "label"
      ],
      "set_id": "48dc8d92-16ee-b359-e063-6294a90a26af",
      "id": "51dbaacf-501a-5b1a-e063-6394a90a4824",
      "effective_time": "20260515",
      "version": "2",
      "openfda": {
        "application_number": [
          "M013"
        ],
        "brand_name": [
          "Acetaminophen Extra Strength"
        ],
        "generic_name": [
          "ACETAMINOPHEN 500MG/15ML"
        ],
        "manufacturer_name": [
          "Aldama Pharmaceuticals, Inc"
        ],
        "product_ndc": [
          "73564-817"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN"
        ],
        "rxcui": [
          "307684"
        ],
        "spl_id": [
          "51dbaacf-501a-5b1a-e063-6394a90a4824"
        ],
        "spl_set_id": [
          "48dc8d92-16ee-b359-e063-6294a90a26af"
        ],
        "package_ndc": [
          "73564-817-08"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "362O9ITL9D"
        ]
      }
    }
  ]
}