{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "CHILDRENS ACETAMINOPHEN Children Acetaminophen Cherry ANHYDROUS CITRIC ACID GLYCERIN MICROCRYSTALLINE CELLULOSE CARBOXYMETHYLCELLULOSE SODIUM POTASSIUM SORBATE WATER SORBITOL SUCRALOSE SUCROSE XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN"
      ],
      "active_ingredient": [
        "Active Ingredient Active ingredient (in each 5mL) Purpose Acetaminophen 160 mg ………………………….........Pain reliever/fever reducer"
      ],
      "purpose": [
        "Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache"
      ],
      "warnings": [
        "Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child takes: more then 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Allergy alert: A cetaminophen 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. Sore throat warning: if sore throat is severe, persist or more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. 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 your child is allergic to acetaminophen or anyof the inactive ingredients in this product. Ask a doctor before use if your child has liver disease. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product, do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if pain gets worse or lasts for more then 5 days fever gets worse or last for more then 3 days new symptoms occur redness or swelling is present. These could be signs of a serious condition. Overdose warning: In case of overdose, get medical help to contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms. Keep out of Reach of children Ask a doctor or pharmacist before use if the child has liver disease. Ask doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if pain gets worse or lasts for more then 5 days fever gets worse or last for more then 3 days new symptoms occur redness or swelling is present. These could be signs of a serious condition. Overdose warning: In case of overdose, get medical help to contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms. Keep out of Reach of children"
      ],
      "ask_doctor": [
        "Ask a doctor or pharmacist before use if the child has liver disease. Ask doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product do not exceed recommended dose (see overdose warning)"
      ],
      "indications_and_usage": [
        "Ask doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product do not exceed recommended dose (see overdose warning)"
      ],
      "stop_use": [
        "Stop use and ask a doctor if pain gets worse or lasts for more then 5 days fever gets worse or last for more then 3 days new symptoms occur redness or swelling is present. These could be signs of a serious condition. Overdose warning: In case of overdose, get medical help to contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of Reach of children"
      ],
      "dosage_and_administration": [
        "Directions this product does not contain directions or complete warnings for adult use shake well before using mL = milliliter find right dose on chart below. if possible, use weight to dose, otherwise use age use only the enclosed dosing cup designed for use with product. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours. * or as directed by a doctor Weight (lbs) Age (yrs.) Dose (tsp or mL) Weight (lbs) Age (yrs.) Dose (tsp or mL) under 24 under 2 ask a doctor 48 to 59 6 to 8 2 tsp or 10 mL 25 to 35 2 to 3 1 tsp or 5 mL 60 to 71 9 to 10 2 1/2 tsp or 12.5 mL 36 to 47 4 to 5 1 1/2 tsp or 7.5 mL 72 to 95 11 2 1/2 tsp or 12.5 mL"
      ],
      "dosage_and_administration_table": [
        "<table width=\"100%\"><caption/><tbody><tr><td>Weight (lbs)</td><td>Age (yrs.)</td><td>Dose (tsp or mL)</td><td>Weight (lbs)</td><td>Age (yrs.)</td><td>Dose (tsp or mL)</td></tr><tr><td>under 24</td><td>under 2</td><td>ask a doctor</td><td>48 to 59</td><td>6 to 8</td><td>2 tsp or 10 mL</td></tr><tr><td>25 to 35</td><td>2 to 3</td><td>1 tsp or 5 mL</td><td>60 to 71</td><td>9 to 10</td><td>2 1/2 tsp or 12.5 mL</td></tr><tr><td>36 to 47</td><td>4 to 5</td><td>1 1/2 tsp or 7.5 mL</td><td>72 to 95</td><td>11</td><td>2 1/2 tsp or 12.5 mL</td></tr></tbody></table>"
      ],
      "storage_and_handling": [
        "Other Information Store at room temperature 20°-25°C (68°-77°F). Protect from freezing. Protect from light."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Anhydrous Citric Acid, Cherry Flavor, Glycerin, Microcrystalline cellulose and Sodium Methyl Cellulose, Potassium Sorbate, Purified Water, Sorbitol, Sucralose, Sucrose, Xanthan gum."
      ],
      "questions": [
        "Questions or comments? call toll-free 1-877-225-6999 Manufactured for: AARNA USA INC. Leland, NC-28451 This product is not manufactured by or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol Suspension."
      ],
      "recent_major_changes": [
        ""
      ],
      "package_label_principal_display_panel": [
        "1 2 3 4 5"
      ],
      "set_id": "3f67317c-f4ad-e51a-e063-6294a90a4408",
      "id": "3f66eda0-2427-955c-e063-6294a90a61a2",
      "effective_time": "20250922",
      "version": "1",
      "openfda": {
        "application_number": [
          "M013"
        ],
        "brand_name": [
          "CHILDRENS ACETAMINOPHEN"
        ],
        "generic_name": [
          "CHILDREN ACETAMINOPHEN CHERRY"
        ],
        "manufacturer_name": [
          "AARNA USA INC."
        ],
        "product_ndc": [
          "82568-0011"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN"
        ],
        "rxcui": [
          "307668"
        ],
        "spl_id": [
          "3f66eda0-2427-955c-e063-6294a90a61a2"
        ],
        "spl_set_id": [
          "3f67317c-f4ad-e51a-e063-6294a90a4408"
        ],
        "package_ndc": [
          "82568-0011-4",
          "82568-0011-8",
          "82568-0011-6"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "362O9ITL9D"
        ]
      }
    }
  ]
}