{
  "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": "2026-10-02",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Dextromethorphan HBr Dextromethorphan HBr DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE, UNSPECIFIED PROPYL GALLATE PROPYLENE GLYCOL WATER SORBITOL SORBITAN T"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "*This product is not manufactured or distributed by the owners of Robitussin® Long-Acting CoughGels®. Tamper-Evident: Do not use if printed seal under cap is missing or damaged Manufactured for: BIONPHARMA Princeton, NJ 08540 Code:TN/Drugs/TN00003701 MADE IN INDIA PML00430 NDC 69452-573-17 L0001304 R0726"
      ],
      "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 you have ■ cough that is accompanied by excessive phlegm (mucus) ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema Stop use and ask doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. I n case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have ■ cough that is accompanied by excessive phlegm (mucus) ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema"
      ],
      "stop_use": [
        "Stop use and ask doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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. I n 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 product is not intended for use in children under 12 years of age adults and children 12 years and over take 2 capsules every 6 to 8 hours, or as directed by a doctor children under 12 years do not use"
      ],
      "dosage_and_administration_table": [
        "<table border=\"1\"><tbody><tr><td>  adults and children   12 years and over </td><td>  take 2 capsules every   6 to 8 hours, or as   directed by a doctor </td></tr><tr><td>children under 12 years</td><td>do not use</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 and moisture"
      ],
      "inactive_ingredient": [
        "Inactive ingredients FD&C Blue No.1, FD&C Red No.40, gelatin, glycerin, pharmaceutical imprinting ink, polyethylene glycol 400, povidone, propylene glycol, propyl gallate, purified water, sorbitol sorbitan solution"
      ],
      "questions": [
        "Questions or comments? call toll-free 1-888-235-2466"
      ],
      "package_label_principal_display_panel": [
        "60's count *compare to the active ingredient in Robitussin® Long-Acting CoughGels® a+ health TM dextromethorphan HBr capsules, 15 mg cough suppressant relieves cough for up to 8 hours for ages 12 & over 60 SOFTGELS** **liquid-filled capsules image-01"
      ],
      "set_id": "5a5dde85-8785-8149-e063-6294a90a4d57",
      "id": "5a5dde7e-05b9-13e7-e063-6394a90a197e",
      "effective_time": "20260831",
      "version": "1",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Dextromethorphan HBr"
        ],
        "generic_name": [
          "DEXTROMETHORPHAN HBR"
        ],
        "manufacturer_name": [
          "BIONPHARMA INC."
        ],
        "product_ndc": [
          "69452-573"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DEXTROMETHORPHAN HYDROBROMIDE"
        ],
        "rxcui": [
          "1090487"
        ],
        "spl_id": [
          "5a5dde7e-05b9-13e7-e063-6394a90a197e"
        ],
        "spl_set_id": [
          "5a5dde85-8785-8149-e063-6294a90a4d57"
        ],
        "package_ndc": [
          "69452-573-17"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "9D2RTI9KYH"
        ]
      }
    }
  ]
}