{
  "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": 24
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "topcare mucus d guaifenesin and pseudoephedrine hydrochloride GUAIFENESIN GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) SILICON DIOXIDE FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE L6"
      ],
      "active_ingredient": [
        "Active ingredients (in each extended-release bi-layer tablet) Guaifenesin 600 mg Pseudoephedrine HCl 60 mg"
      ],
      "purpose": [
        "Purposes 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 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 a 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 a 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"
      ],
      "storage_and_handling": [
        "Other information • do not use if printed blister unit is broken or torn • store between 20-25˚C (68-77˚F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients carbomer homopolymer type B, colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate"
      ],
      "questions": [
        "Questions or comments? 1-888-423-0139"
      ],
      "package_label_principal_display_panel": [
        "Package/Label Principal Display Panel TopCare ® health COMPARE TO MUCINEX ® D ACTIVE INGREDIENTS Mucus-D GUAIFENESIN 600 mg PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg EXTENDED-RELEASE BI-LAYER TABLETS EXPECTORANT/NASAL DECONGESTANT 12 HOUR • Clears Nasal/Sinus Congestion • Thins And Loosens Mucus • Immediate and Extended Release 18 EXTENDED-RELEASE BI-LAYER TABLETS actual size mucus-d-image"
      ],
      "set_id": "02134afa-ae8c-4678-a19a-7fd3cab5782f",
      "id": "784ad93e-f3b9-48a8-beff-e2aae8b5e147",
      "effective_time": "20230830",
      "version": "2",
      "openfda": {
        "application_number": [
          "ANDA214407"
        ],
        "brand_name": [
          "topcare mucus d"
        ],
        "generic_name": [
          "GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Topco Associates LLC"
        ],
        "product_ndc": [
          "76162-801"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "GUAIFENESIN",
          "PSEUDOEPHEDRINE HYDROCHLORIDE"
        ],
        "spl_id": [
          "784ad93e-f3b9-48a8-beff-e2aae8b5e147"
        ],
        "spl_set_id": [
          "02134afa-ae8c-4678-a19a-7fd3cab5782f"
        ],
        "package_ndc": [
          "76162-801-89"
        ],
        "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"
        ]
      }
    }
  ]
}