{
  "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": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mL Acetaminophen 160 mg / 5 mL WATER SODIUM BENZOATE SUCRALOSE ANHYDROUS CITRIC ACID SORBITOL SOLUTION 70% FD&C RED NO. 40 XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN GLYCERIN SUCROSE"
      ],
      "active_ingredient": [
        "Active ingredient (in each 5 mL) Acetaminophen 160 mg"
      ],
      "purpose": [
        "Purpose Pain reliever/fever reducer"
      ],
      "indications_and_usage": [
        "Uses Temporarily reduces fever Temporarily 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 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. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly."
      ],
      "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 your child is 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 or pharmacist before use if your child is taking the blood thinning drug warfarin."
      ],
      "when_using": [
        "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 more than 5 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."
      ],
      "overdosage": [
        "Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"
      ],
      "dosage_and_administration": [
        "Directions this product does not contain directions or complete warnings for adult use. do not give more than directed (see overdose warning) Follow the instruction given on this carton for your easy use. Age (Years) Dose (mL)* Under 2 Years Ask a doctor 2 to under 6 1 Sachet (5 mL) 6 to 11 years 2 Sachets (10 mL) *dose may be repeated every 4 hours while symptoms persist, upto five times a day or as directed by a doctor. mL = milliliter"
      ],
      "dosage_and_administration_table": [
        "<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\"><tbody><tr><td><paragraph><content styleCode=\"bold\">Age (Years)</content></paragraph></td><td><paragraph><content styleCode=\"bold\">Dose (mL)*</content></paragraph></td></tr><tr><td><paragraph>Under 2 Years</paragraph></td><td><paragraph>Ask a doctor</paragraph></td></tr><tr><td><paragraph>2 to under 6</paragraph></td><td><paragraph>1 Sachet (5 mL)</paragraph></td></tr><tr><td><paragraph>6 to 11 years</paragraph></td><td><paragraph>2 Sachets (10 mL)</paragraph></td></tr></tbody></table>"
      ],
      "recent_major_changes": [
        "Change in Direction"
      ],
      "storage_and_handling": [
        "Other information store between 20-25°C (68-77°F) do not use if carton or sachet is torn, broken or punctured."
      ],
      "inactive_ingredient": [
        "Inactive Ingredient anhydrous citric acid, FD&C Red No. 40, flavors, glycerin, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose, xanthan gum"
      ],
      "questions": [
        "Question or Comments? call 1-516-675-8915"
      ],
      "package_label_principal_display_panel": [
        "NDC 87078-121-52"
      ],
      "set_id": "40507559-aee4-a603-e063-6394a90afc4f",
      "id": "40507559-aee5-a603-e063-6394a90afc4f",
      "effective_time": "20251004",
      "version": "1",
      "openfda": {
        "application_number": [
          "M013"
        ],
        "brand_name": [
          "OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mL"
        ],
        "generic_name": [
          "ACETAMINOPHEN 160 MG / 5 ML"
        ],
        "manufacturer_name": [
          "MEDWISE LIFESCIENCES INC."
        ],
        "product_ndc": [
          "87078-121"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN"
        ],
        "rxcui": [
          "307668"
        ],
        "spl_id": [
          "40507559-aee5-a603-e063-6394a90afc4f"
        ],
        "spl_set_id": [
          "40507559-aee4-a603-e063-6394a90afc4f"
        ],
        "package_ndc": [
          "87078-121-52"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0850078212016"
        ],
        "unii": [
          "362O9ITL9D"
        ]
      }
    }
  ]
}