{
  "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": [
        "MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE Hexylresorcinol and Menthol HEXYLRESORCINOL HEXYLRESORCINOL MENTHOL MENTHOL D&C YELLOW NO. 10 ISOMALT FD&C BLUE NO. 1 FD&C RED NO. 40 SUCRALOSE WATER HYDROGENATED STARCH HYDROLYSATE pale brown/yellow S Honey and Lemon"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Dist. by: Reckitt Benckiser Nutley, NJ 07110-6100"
      ],
      "active_ingredient": [
        "Active ingredients (in each lozenge) Hexylresorcinol 2 mg Menthol 6.1 mg"
      ],
      "purpose": [
        "Purpose Hexylresorcinol 2 mg - Oral pain reliever Menthol 6.1 mg - Cough suppressant"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves: ■ occasional minor irritation and pain due to a sore mouth or sore throat ■ pain associated with canker sores ■ cough due to minor throat and bronchial irritation as may occur with the common cold"
      ],
      "warnings": [
        "Warnings Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. Do not use in children under 6 years of age When using this product do not exceed recommended dosage Ask a doctor before use if you have ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough accompanied by excessive phlegm (mucus) Stop use and ask a doctor or dentist if ■ sore mouth symptoms do not improve in 7 days ■ irritation, pain, or redness persists or worsens ■ cough lasts more than 7 days, comes back, or occurs with 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 in children under 6 years of age"
      ],
      "when_using": [
        "When using this product do not exceed recommended dosage"
      ],
      "stop_use": [
        "Ask a doctor before use if you have ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough accompanied by excessive phlegm (mucus) Stop use and ask a doctor or dentist if ■ sore mouth symptoms do not improve in 7 days ■ irritation, pain, or redness persists or worsens ■ cough lasts more than 7 days, comes back, or occurs with 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 ■ adults and children 6 years of age and older: allow one lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist. ■ children under 6 years of age: do not use"
      ],
      "storage_and_handling": [
        "Other information store at 20-25°C (68-77°F) protect contents from humidity keep lozenge in outer pack until use. Reseal outer pack after use."
      ],
      "inactive_ingredient": [
        "Inactive ingredients D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavor, hydrogenated starch hydrolysate, isomalt, purified water, sucralose"
      ],
      "questions": [
        "Questions? 1-866-MUCINEX (1-866-682-4639)"
      ],
      "recent_major_changes": [
        ""
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL 72854-268 front label 72854-268 back label"
      ],
      "set_id": "4a938e15-a996-8538-e063-6294a90ad4ee",
      "id": "5a6f82bb-8b33-af4f-e063-6394a90a7ed8",
      "effective_time": "20260901",
      "version": "4",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE"
        ],
        "generic_name": [
          "HEXYLRESORCINOL AND MENTHOL"
        ],
        "manufacturer_name": [
          "Reckitt Benckiser LLC"
        ],
        "product_ndc": [
          "72854-268"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HEXYLRESORCINOL",
          "MENTHOL"
        ],
        "rxcui": [
          "2744293"
        ],
        "spl_id": [
          "5a6f82bb-8b33-af4f-e063-6394a90a7ed8"
        ],
        "spl_set_id": [
          "4a938e15-a996-8538-e063-6294a90ad4ee"
        ],
        "package_ndc": [
          "72854-268-32"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "R9QTB5E82N",
          "L7T10EIP3A"
        ]
      }
    }
  ]
}