{
  "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": [
        "Maximum Strength Mucus Relief Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL PROPYL GALLATE WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE XANTHAN GUM mixed berry"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENTS (in each 20 mL) Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCI 10 mg"
      ],
      "purpose": [
        "PURPOSE Cough suppressant Expectorant Nasal decongestant"
      ],
      "indications_and_usage": [
        "USE(S) • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive • temporarily relieves: • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the intensity of coughing • the impulse to cough to help you get to sleep • nasal congestion due to a cold"
      ],
      "warnings": [
        "WARNINGS ."
      ],
      "do_not_use": [
        "DO NOT USE • for children under 12 years of age • 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 that occurs with too much phlegm (mucus)"
      ],
      "when_using": [
        "WHEN USING THIS PRODUCT • do not use more than directed"
      ],
      "stop_use": [
        "STOP USE AND ASK DOCTOR IF nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough comes back, or occurs with rash or persistent headache. These could be signs of a serious condition."
      ],
      "pregnancy_or_breast_feeding": [
        "PREGNANCY/BREASTFEEDING 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 6 doses in any 24-hour period • measure only with dosing cup provided • do not use dosing cup with other products • dose as follows or as directed by a doctor • Adults and children 12 years and olde r: 20 ml in dosing cup provided every 4 hours . • Children under 12 years of age : Do not use"
      ],
      "other_safety_information": [
        "OTHER INFORMATION • each 20 ml contains : sodium 20 mg • store between 15-30ºC (59-86ºF) • do not refrigerate • dosing cup provided"
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS citric acid anhydrous, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL HyVee *Compare to the Active Ingredients in Maximum Strength Mucinex ® Fax Max TM Severe Congestion & Cough Maximum Strength Mucus Relief Sever Congestion & Cough Cough suppressant/ Expectorant/ Nasal decongestant Control Cough Relieves Nasal & Chest Congestion Thins and Loosens Mucus 6 FL OZ (177 mL) 617-6-hyvee-f.jpg 617-6-hyvee-b.jpg"
      ],
      "set_id": "4e578c7a-88d4-e4cd-e063-6394a90aac44",
      "id": "401bb6f2-21f5-43ef-8709-ae8338b2a7bc",
      "effective_time": "20260827",
      "version": "3",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Maximum Strength Mucus Relief"
        ],
        "generic_name": [
          "DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL"
        ],
        "manufacturer_name": [
          "Hyvee Inc"
        ],
        "product_ndc": [
          "42507-617"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "GUAIFENESIN",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1043543"
        ],
        "spl_id": [
          "401bb6f2-21f5-43ef-8709-ae8338b2a7bc"
        ],
        "spl_set_id": [
          "4e578c7a-88d4-e4cd-e063-6394a90aac44"
        ],
        "package_ndc": [
          "42507-617-58"
        ],
        "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": [
          "9D2RTI9KYH",
          "495W7451VQ",
          "04JA59TNSJ"
        ]
      }
    }
  ]
}