{
  "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": 7
    }
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  "results": [
    {
      "spl_product_data_elements": [
        "Mucinex Childrens Mighty Chews Cough Nighttime Dextromethorphan HBr and Doxylamine Succinate FD&C RED NO. 40 MALTODEXTRIN PECTIN POTASSIUM SODIUM TARTRATE WATER GLYCERIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN MALIC ACID CORN SYRUP FD&C BLUE NO. 1 SODIUM CHLORIDE ANHYDROUS TRISODIUM CITRATE SUCRALOSE SODIUM POLYMETAPHOSPHATE SUCROSE DOXYLAMINE SUCCINATE DOXYLAMINE ANHYDROUS CITRIC ACID Mixed Berry M"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredients (in each chewable tablet) Dextromethorphan HBr 10 mg Doxylamine Succinate 6.25 mg"
      ],
      "purpose": [
        "Dextromethorphan HBr 10 mg.......................... ...............Cough suppressant Doxylamine succinate 6.25 mg.................................................Antihistamine"
      ],
      "indications_and_usage": [
        "Uses ■ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold ■ controls cough to help you get to sleep ■ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes"
      ],
      "warnings": [
        "Warnings Do not use ■ to make a child sleepy ■ 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 ■ a sodium-restricted diet ■ glaucoma ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are ■ taking sedatives or tranquilizers When using this product ■ do not exceed recommended dosage ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if ■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition."
      ],
      "keep_out_of_reach_of_children": [
        "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"
      ],
      "dosage_and_administration": [
        "Directions ■ take every 4 hours, or as directed by a doctor ■ chew thoroughly before swallowing ■ do not swallow whole adults and children 12 years of age and over 2 chewable tablets every 4 hours, not to exceed 12 chewable tablets in any 24-hour period children 6 to under 12 years of age 1 chewable tablet every 4 hours, not to exceed 6 chewable tablets in any 24-hour period children under 6 years of age do not use"
      ],
      "dosage_and_administration_table": [
        "<table border=\"0\"><tbody><tr><td>adults and children 12 years   of age and over </td><td>2 chewable tablets every 4 hours, not to exceed   12 chewable tablets in any 24-hour period </td></tr><tr><td>children 6 to under 12 years   of age </td><td>1 chewable tablet every 4 hours, not to exceed   6 chewable tablets in any 24-hour period </td></tr><tr><td>children under 6 years of age</td><td>do not use</td></tr></tbody></table>"
      ],
      "other_safety_information": [
        "Other information ■ each chewable tablet contains: potassium 5 mg and sodium 15 mg ■ Store in a cool dry place at 20-25°C (68-77°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients anhydrous citric acid, corn syrup, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, malic acid, maltodextrin, pectin, potassium sodium tartrate, purified water, sodium chloride, sodium polymetaphosphate, sucralose, sucrose, trisodium citrate (anhydrous)"
      ],
      "questions": [
        "Questions? 1-866-MUCINEX (1-866-682-4639)"
      ],
      "recent_major_changes": [
        ""
      ],
      "package_label_principal_display_panel": [
        "Mucinex Childrens Mighty Chews Cough Nighttime 1 Mucinex Childrens Mighty Chews Cough Nighttime 2"
      ],
      "set_id": "156033ae-b16a-007b-e063-6294a90a7445",
      "id": "531e853d-03ed-6e23-e063-6294a90afb0f",
      "effective_time": "20260531",
      "version": "4",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Mucinex Childrens Mighty Chews Cough Nighttime"
        ],
        "generic_name": [
          "DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE"
        ],
        "manufacturer_name": [
          "Reckitt Benckiser LLC"
        ],
        "product_ndc": [
          "72854-082"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "DOXYLAMINE SUCCINATE"
        ],
        "spl_id": [
          "531e853d-03ed-6e23-e063-6294a90afb0f"
        ],
        "spl_set_id": [
          "156033ae-b16a-007b-e063-6294a90a7445"
        ],
        "package_ndc": [
          "72854-082-16"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363824997896"
        ],
        "unii": [
          "9D2RTI9KYH",
          "V9BI9B5YI2"
        ]
      }
    }
  ]
}