{
  "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": 99
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Mucus Relief D Guaifenesin and Pseudoephedrine HCL Guaifenesin Guaifenesin Pseudoephedrine Hydrochloride Pseudoephedrine FD&C YELLOW NO. 6 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE SILICON DIOXIDE RDY;799 Carton"
      ],
      "active_ingredient": [
        "Active ingredients (in each extended-release tablet) Guaifenesin USP, 600 mg................................................................................Expectorant Pseudoephedrine HCl USP, 60 mg......................................................Nasal Decongestant"
      ],
      "purpose": [
        "Purpose Expectorant and 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 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 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 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: 2 tablets every 12 hours; not more than 4 tablets in 24 hours children under 12 years of age: do not use"
      ],
      "spl_unclassified_section": [
        "Other information tamper evident: do not use if carton is open or if printed seal on blister is broken or missing store between 20° - 25°C (68° - 77°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients FD & C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide."
      ],
      "questions": [
        "Questions? call 1-888-375-3784 You may also report side effect to this phone number."
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel"
      ],
      "set_id": "01047716-389b-df25-ebe6-c897fc47d3df",
      "id": "9a13bb97-fe92-b12e-9847-8546870add92",
      "effective_time": "20251210",
      "version": "9",
      "openfda": {
        "application_number": [
          "ANDA208369"
        ],
        "brand_name": [
          "Mucus Relief D"
        ],
        "generic_name": [
          "GUAIFENESIN AND PSEUDOEPHEDRINE HCL"
        ],
        "manufacturer_name": [
          "Walgreens Company"
        ],
        "product_ndc": [
          "0363-1604"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "GUAIFENESIN",
          "PSEUDOEPHEDRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1305603"
        ],
        "spl_id": [
          "9a13bb97-fe92-b12e-9847-8546870add92"
        ],
        "spl_set_id": [
          "01047716-389b-df25-ebe6-c897fc47d3df"
        ],
        "package_ndc": [
          "0363-1604-20",
          "0363-1604-40",
          "0363-1604-15",
          "0363-1604-37"
        ],
        "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"
        ]
      }
    }
  ]
}