{
  "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,
      "total": 9
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Leader Mucus Relief D guaifenesin, pseudoephedrine hydrochloride GUAIFENESIN GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) SILICON DIOXIDE FD&C YELLOW NO. 6 ALUMINUM LAKE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A L12"
      ],
      "active_ingredient": [
        "Active ingredients (in each extended-release tablet) Guaifenesin 1200 mg Pseudoephedrine HCl 120 mg"
      ],
      "purpose": [
        "Purposes Expectorant Nasal Decongestant"
      ],
      "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 nasal congestion due to: • common cold • hay fever • upper respiratory allergies • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • temporarily relieves sinus congestion and pressure"
      ],
      "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 • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus) When using this product • do not use more than directed Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness. 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 (1-800-222-1222)."
      ],
      "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 • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus)"
      ],
      "when_using": [
        "When using this product • do not use more than directed"
      ],
      "stop_use": [
        "Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness."
      ],
      "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 (1-800-222-1222)."
      ],
      "dosage_and_administration": [
        "Directions • do not crush, chew, or break extended-release tablet • take with a full glass of water • this product can be administered without regard for timing of meals • adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours • children under 12 years of age: do not use"
      ],
      "other_safety_information": [
        "Other information • store at 20-25°C (68-77°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients carbomer homopolymer type B, colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate"
      ],
      "questions": [
        "Questions or comments? 1-800-719-9260"
      ],
      "package_label_principal_display_panel": [
        "Package/Label Principal Display Panel LEADER ™ Maximum Strength Mucus Relief D Guaifenesin, 1200 mg Pseudoephedrine Hydrochloride, 120 mg Extended-Release Tablets Expectorant | Nasal Decongestant RELIEVES NASAL & CHEST CONGESTION 12-Hour Clears Nasal & Sinus Congestion Thins & Loosens Mucus Immediate & Extended Release Actual Size COMPARE TO MUCINEX ® D MAXIMUM STRENGTH active ingredients 100% Money Back Guarantee 24 EXTENDED-RELEASE TABLETS mucus-relief-d"
      ],
      "set_id": "12971fb2-2314-4443-bf70-b7eb5859b148",
      "id": "1a7ee5d9-d68a-4df4-ac73-21002330b66a",
      "effective_time": "20260526",
      "version": "3",
      "openfda": {
        "application_number": [
          "ANDA214407"
        ],
        "brand_name": [
          "Leader Mucus Relief D"
        ],
        "generic_name": [
          "GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Cardinal Health 110, LLC. dba Leader"
        ],
        "product_ndc": [
          "70000-0719"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "GUAIFENESIN",
          "PSEUDOEPHEDRINE HYDROCHLORIDE"
        ],
        "spl_id": [
          "1a7ee5d9-d68a-4df4-ac73-21002330b66a"
        ],
        "spl_set_id": [
          "12971fb2-2314-4443-bf70-b7eb5859b148"
        ],
        "package_ndc": [
          "70000-0719-1"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000193956",
          "N0000008867",
          "N0000009560"
        ],
        "pharm_class_epc": [
          "Expectorant [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Respiratory Secretion Viscosity [PE]",
          "Increased Respiratory Secretions [PE]"
        ],
        "unii": [
          "495W7451VQ",
          "6V9V2RYJ8N"
        ]
      }
    }
  ]
}