{
  "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,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "BRONCOCHEM MAXIMUM COUGH NIGHT DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PYRILAMINE MALEATE PYRILAMINE SUGARCANE SODIUM BENZOATE FD&C YELLOW NO. 5 ORANGE OIL METHYLPARABEN SODIUM PROPYLPARABEN SODIUM ALCOHOL 95% SORBITOL SOLUTION 70% water"
      ],
      "warnings": [
        "Warnings The following side effects may occur, nausea, vomiting, dizziness, headache, or nervousness may occur, if any of these effects last or worsen, contact your doctor or pharmacist immediately. Stop using this medicine and tell your doctor right away if you have dizziness, nervousness, or trouble sleeping."
      ],
      "purpose": [
        "OTC-PURPOSE SECTION Antitussive Antihistamine"
      ],
      "active_ingredient": [
        "OTC - Active Ingredient Section Dextromethorphan HBr Mepyramine maleate"
      ],
      "indications_and_usage": [
        "Uses Temporarily relieves these symptoms in all formsof acute, subacute, and cronical cough of any origin, it is very effective in colds, rhinitis, pharyngitis, laryngitis, dry cough, smokers cough, ashma, nervous cough."
      ],
      "do_not_use": [
        "Do Not Use Stop using this medicine and contact your doctor right away if any of these unlikely but serious side effects occur, fast and irregular heartbeat, mental mood changes such as confusion, hallucinations, nervousness, seizures, tremor, problems with to pee. If you are taking any monoamine oxidase inhibitor (MAOI), or two weeks after stopping them (certain medications for depression or psycological conditions may contain them). If you are not sure if your prescription contains an MAOI, coinsult a professional of health before taking this product."
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor/pharmacist Ask a doctor before use if yoy have Liver disease, heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to enlarged prostate gland, cough that occurs with too much phlegm (mucus), presistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema."
      ],
      "stop_use": [
        "Stop use and ask a doctor if Symptoms last more than 7 days, symptoms worsen or come back, you develop a headache that wont go away, fever, or skin rash. If pregnant or breast-feeding ask a health professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep Out of the Reach of Children In case of accidental overdose, seek professional help or go to poison control center immediately."
      ],
      "dosage_and_administration": [
        "Dosage and Administration Do not exceed 4 doses in a 24 hour period. Adult and children 12 years and older: (5 or 10 mL) 3 times a day. Children between 6 to 12 years old: (2.5 mL) 3 times a day."
      ],
      "inactive_ingredient": [
        "Inactive Ingredient Sugar, Sodium Benzoate, FD&C Yellow #5, Orange flavor, MEthyl paraben, Propyl paraben, ethyl alcohol 95%, Sorbitol 70%, Purified water."
      ],
      "package_label_principal_display_panel": [
        "PACKAGE LABEL PRINCIPAL DISPLAY PANEL Broncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpg",
        "PACKAGE LABEL PRINCIPAL DISPLAY PANEL BroncochemMaximumCoughNight_BoxProductionFile_v3 (002)-01.jpg"
      ],
      "set_id": "1a3ed214-e09b-4266-b68b-39e7c3127d26",
      "id": "5c804db7-1a93-4b7c-9c07-11cd3e80e246",
      "effective_time": "20240422",
      "version": "3",
      "openfda": {
        "application_number": [
          "M"
        ],
        "brand_name": [
          "BRONCOCHEM MAXIMUM COUGH NIGHT"
        ],
        "generic_name": [
          "DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE"
        ],
        "manufacturer_name": [
          "LABORATORIO MAGNACHEM INTERNATIONAL SRL"
        ],
        "product_ndc": [
          "65131-035"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "PYRILAMINE MALEATE"
        ],
        "rxcui": [
          "2679777"
        ],
        "spl_id": [
          "5c804db7-1a93-4b7c-9c07-11cd3e80e246"
        ],
        "spl_set_id": [
          "1a3ed214-e09b-4266-b68b-39e7c3127d26"
        ],
        "package_ndc": [
          "65131-035-80"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0805418091080"
        ],
        "unii": [
          "9D2RTI9KYH",
          "R35D29L3ZA"
        ]
      }
    }
  ]
}