{
  "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": [
        "Nighttime Cold and Flu Acetaminophen, Dextromethorphan, Doxylamine succinate GLYCERIN ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE"
      ],
      "dosage_and_administration": [
        "Directions take only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use"
      ],
      "warnings": [
        "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hrs, which is the maximum daily amount for this product 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 skin reaction occurs, stop use and seek medical help right away Sore throat warning: If sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly."
      ],
      "inactive_ingredient": [
        "Inactive ingredients alcohol, citric acid, D&C Yellow No. 10, FD&C Blue No.1, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose and sneezing"
      ],
      "keep_out_of_reach_of_children": [
        "If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms"
      ],
      "purpose": [
        "Active Ingredients (in each 30 mL) Purpose Acetaminophen 650 mg……………………………………………………………………………………………………………….……….. Pain reliever/fever reducer Dextromethorphan HBr 30 mg…………………………………………………………………………………………………….….………….……. Cough suppressant Doxylamine succinate 12.5 mg………………………………………………………………………………………………………………………….……. Antihistamine"
      ],
      "package_label_principal_display_panel": [
        "fre fre2"
      ],
      "set_id": "02e5f475-4e9f-2856-e063-6294a90a21fd",
      "id": "494e1d98-d19b-7f9c-e063-6294a90ab6c5",
      "effective_time": "20260126",
      "version": "3",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Nighttime Cold and Flu"
        ],
        "generic_name": [
          "ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATE"
        ],
        "manufacturer_name": [
          "Walgreen Company"
        ],
        "product_ndc": [
          "0363-9143"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "DOXYLAMINE SUCCINATE"
        ],
        "spl_id": [
          "494e1d98-d19b-7f9c-e063-6294a90ab6c5"
        ],
        "spl_set_id": [
          "02e5f475-4e9f-2856-e063-6294a90a21fd"
        ],
        "package_ndc": [
          "0363-9143-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "362O9ITL9D",
          "9D2RTI9KYH",
          "V9BI9B5YI2"
        ]
      }
    }
  ]
}