{
  "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
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Mucus Relief Congestion and Cough Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYL GALLATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SORBITOL SUCRALOSE XANTHAN GUM"
      ],
      "active_ingredient": [
        "Active ingredients (in each 20 mL) Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg"
      ],
      "purpose": [
        "Purposes Cough suppressant 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 cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritant 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 if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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. for children under 12 years of age 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, emphysema cough that occurs with too much phlegm (mucus) When using this product do not use more than directed. Stop use and ask a 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 fever, rash, or headache that lasts. 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 (1-800-222-1222) right away."
      ],
      "do_not_use": [
        "Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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. for children under 12 years of age"
      ],
      "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, 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 a 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 fever, rash, or headache that lasts. 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 (1-800-222-1222) 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 any other dosing device keep dosing cup with product mL= milliliter shake well before using adult and children 12 years of age and older: 20 mL in dosing cup provided avery 4 hours Children under 12 years of age do not use"
      ],
      "storage_and_handling": [
        "Other information each 20 mL contains: sodium 17 mg store between 20-25ºC (68-77ºF). Do not refrigerate."
      ],
      "inactive_ingredient": [
        "Inactive ingredients citric acid, disodium EDTA, FD&C blue #1 FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose,xanthan gum"
      ],
      "questions": [
        "Questions or comments? Call 1-800-910-6874"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Compare to active ingredients in Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough* maximum strength fast mucus relief severe congestion and cough dextromethorphan HBr 20 mg (cough suppressant) guaifenesin 400 mg (expectorant) phenylephrine HCI 10 mg (nasal decongestant) controls cough relieves nasal and chest congestion thins and loosens mucus AGES 12 + YEARS *This product is not manufactured or distributed by Reckitt Benckiser, distributor of maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. Dist. by Target Corp. Minneapolis, MN 55403",
        "Product Label TARGET Maximum Strength Mucus Relief Severe Congestion and Cough Dextromethorphan HBr 20 mg, Guaifenesin 400 mg, Phenylephrine HCl 10 mg"
      ],
      "set_id": "1bf9a59e-cc37-4780-ba75-7138c546eb19",
      "id": "096744aa-de92-4177-81eb-6e61bb1b3ea9",
      "effective_time": "20260902",
      "version": "6",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Mucus Relief Congestion and Cough Maximum Strength"
        ],
        "generic_name": [
          "DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI"
        ],
        "manufacturer_name": [
          "TARGET Corporation"
        ],
        "product_ndc": [
          "11673-337"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "GUAIFENESIN",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1043543"
        ],
        "spl_id": [
          "096744aa-de92-4177-81eb-6e61bb1b3ea9"
        ],
        "spl_set_id": [
          "1bf9a59e-cc37-4780-ba75-7138c546eb19"
        ],
        "package_ndc": [
          "11673-337-06"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0349580337060"
        ],
        "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"
        ]
      }
    }
  ]
}