{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Mucus Relief DM Cough Maximum Strength Dextromethorphan HBr and Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN D&C YELLOW NO. 10 ALUMINUM LAKE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID 44;533"
      ],
      "active_ingredient": [
        "Active ingredients (in each immediate-release tablet) Dextromethorphan HBr 20 mg Guaifenesin 400 mg"
      ],
      "purpose": [
        "Purpose Cough suppressant Expectorant"
      ],
      "indications_and_usage": [
        "Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation associated with the common cold the intensity of coughing the impulse to cough to help you get to sleep"
      ],
      "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 accompanied by too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema When using this product do not exceed recommended dosage. Stop use and ask a doctor if cough persists more than 1 week, tends to recur, or is accompanied by a 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 you have cough accompanied by too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema"
      ],
      "when_using": [
        "When using this product do not exceed recommended dosage."
      ],
      "stop_use": [
        "Stop use and ask a doctor if cough persists more than 1 week, tends to recur, or is accompanied by a 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 directed adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: do not use"
      ],
      "storage_and_handling": [
        "Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN see end flap for expiration date and lot number store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients D&C yellow #10 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid"
      ],
      "questions": [
        "Questions or comments? 1-800-426-9391"
      ],
      "package_label_principal_display_panel": [
        "Principal display panel LEADER ™ NDC 70000-0278-1 Maximum Strength Mucus Relief DM Cough Dextromethorphan HBr, 20 mg ι Guaifenesin, 400 mg Cough Suppressant ι Expectorant Controls Cough Thins and Loosens Mucus Immediate-Release Tablets 24 TABLETS ACTUAL SIZE 100% Money Back Guarantee Leader 44-533 Leader 44-533"
      ],
      "set_id": "6304a581-9238-4539-b157-293fc05c173e",
      "id": "97ccb4a8-35dd-4dfc-a3da-30d032598fb5",
      "effective_time": "20260821",
      "version": "17",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Mucus Relief DM Cough Maximum Strength"
        ],
        "generic_name": [
          "DEXTROMETHORPHAN HBR AND GUAIFENESIN"
        ],
        "manufacturer_name": [
          "Cardinal Health 110, LLC. DBA Leader"
        ],
        "product_ndc": [
          "70000-0278"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "GUAIFENESIN"
        ],
        "rxcui": [
          "1147685"
        ],
        "spl_id": [
          "97ccb4a8-35dd-4dfc-a3da-30d032598fb5"
        ],
        "spl_set_id": [
          "6304a581-9238-4539-b157-293fc05c173e"
        ],
        "package_ndc": [
          "70000-0278-1",
          "70000-0278-2"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0096295131802"
        ],
        "nui": [
          "N0000193956",
          "N0000008867",
          "N0000009560"
        ],
        "pharm_class_epc": [
          "Expectorant [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Respiratory Secretion Viscosity [PE]",
          "Increased Respiratory Secretions [PE]"
        ],
        "unii": [
          "9D2RTI9KYH",
          "495W7451VQ"
        ]
      }
    }
  ]
}