{
  "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": "2026-10-21",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Dextromethorphan HBr 15 mg Dextromethorphan HBr FD&C RED NO. 40 FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE WATER PROPYLENE GLYCOL SORBITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN CLEAR OVAL PC6"
      ],
      "active_ingredient": [
        "Active ingredient (in each softgel) Dextromethorphan HBr, USP 15 mg"
      ],
      "purpose": [
        "Purpose Cough suppressant"
      ],
      "indications_and_usage": [
        "Use temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold"
      ],
      "warnings": [
        "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if the user has a cough that occurs with too much phlegm (mucus) a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. 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."
      ],
      "do_not_use": [
        "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product."
      ],
      "ask_doctor": [
        "Ask a doctor before use if the user has a cough that occurs with too much phlegm (mucus) a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema"
      ],
      "stop_use": [
        "Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions do not take more than 8 capsules in any 24-hour period this adult product is not intended for use in children under 12 years of age adults and children 12 years of age and over take 2 capsules every 6 to 8 hours, as needed children under 12 years of age do not use"
      ],
      "dosage_and_administration_table": [
        "<table border=\"1\"><tbody><tr><td><paragraph>adults and children 12 years of age and over</paragraph></td><td><paragraph> take 2 capsules every 6 to 8 hours, as needed</paragraph></td></tr><tr><td><paragraph>children under 12 years of age</paragraph></td><td><paragraph> do not use</paragraph></td></tr></tbody></table>"
      ],
      "storage_and_handling": [
        "Other information store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F) protect from light"
      ],
      "inactive_ingredient": [
        "Inactive ingredients FD&C blue #1, FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. Wuhan, Hubei 430206, China"
      ],
      "questions": [
        "Questions or comments? Call toll free 1-855-215-8180"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - Shipping Label Dextromethorphan HBr Capsules, 15 mg Quantity : 12000 Capsules NDC No. : 53345-011-01 IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. CAUTION : \"FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING\" Shipping Label"
      ],
      "set_id": "028b025e-2dde-4bef-ba7b-61774e855b4b",
      "id": "2767cee1-e298-26d6-e063-6294a90ab8b8",
      "effective_time": "20241121",
      "version": "3",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Dextromethorphan HBr 15 mg"
        ],
        "generic_name": [
          "DEXTROMETHORPHAN HBR"
        ],
        "manufacturer_name": [
          "Humanwell PuraCap Pharmaceutical (Wuhan), Ltd."
        ],
        "product_ndc": [
          "53345-011"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DEXTROMETHORPHAN HYDROBROMIDE"
        ],
        "rxcui": [
          "1090487"
        ],
        "spl_id": [
          "2767cee1-e298-26d6-e063-6294a90ab8b8"
        ],
        "spl_set_id": [
          "028b025e-2dde-4bef-ba7b-61774e855b4b"
        ],
        "package_ndc": [
          "53345-011-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "9D2RTI9KYH"
        ]
      }
    }
  ]
}