{
  "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": [
        "Cough and Cold HBP Chlorpheniramine maleate, Dextromethorphan HBr CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN CROSCARMELLOSE SODIUM D&C RED NO. 27 ALUMINUM LAKE FD&C YELLOW NO. 6 ALUMINUM LAKE ANHYDROUS LACTOSE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE 44;689"
      ],
      "active_ingredient": [
        "Active ingredients (in each tablet) Chlorpheniramine maleate 4 mg Dextromethorphan HBr 30 mg"
      ],
      "purpose": [
        "Purpose Antihistamine Cough suppressant"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold temporarily relieves runny nose and sneezing due to the common cold"
      ],
      "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 difficulty in urination due to enlargement of the prostate gland cough that occurs with excessive phlegm (mucus) glaucoma a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product excitability may occur, especially in children marked drowsiness may occur avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if cough persists more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. 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 right away."
      ],
      "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 difficulty in urination due to enlargement of the prostate gland cough that occurs with excessive phlegm (mucus) glaucoma a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, or emphysema"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers."
      ],
      "when_using": [
        "When using this product excitability may occur, especially in children marked drowsiness may occur avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness"
      ],
      "stop_use": [
        "Stop use and ask a doctor if cough persists more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. 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 right away."
      ],
      "dosage_and_administration": [
        "Directions do not take more than directed adults and children 12 years and over: 1 tablet every 6 hours, not more than 4 tablets in 24 hours children under 12 years: do not use"
      ],
      "storage_and_handling": [
        "Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number"
      ],
      "inactive_ingredient": [
        "Inactive ingredients croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide"
      ],
      "questions": [
        "Questions or comments? 1-888-423-0139"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel TopCare ® health NDC 36800-689-21 ♥︎FOR PEOPLE WITH HIGH BLOOD PRESSURE COMPARE TO CORICIDIN ® HBP COUGH & COLD ACTIVE INGREDIENTS* Cough & Cold HBP CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HBr ANTIHISTAMINE • COUGH SUPPRESSANT RELIEVES: • Cough • Runny Nose • Sneezing DECONGESTANT-FREE 16 TABLETS actual size TopCare 44-689 TopCare 44-689"
      ],
      "set_id": "ed576bf1-3949-423e-af2e-e4b1a3839b21",
      "id": "8e70ca70-22ec-4783-a25e-0a2e2c5fd317",
      "effective_time": "20260904",
      "version": "14",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Cough and Cold HBP"
        ],
        "generic_name": [
          "CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR"
        ],
        "manufacturer_name": [
          "Topco Associates, LLC"
        ],
        "product_ndc": [
          "36800-689"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CHLORPHENIRAMINE MALEATE",
          "DEXTROMETHORPHAN HYDROBROMIDE"
        ],
        "rxcui": [
          "1421985"
        ],
        "spl_id": [
          "8e70ca70-22ec-4783-a25e-0a2e2c5fd317"
        ],
        "spl_set_id": [
          "ed576bf1-3949-423e-af2e-e4b1a3839b21"
        ],
        "package_ndc": [
          "36800-689-21"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0036800414730"
        ],
        "unii": [
          "V1Q0O9OJ9Z",
          "9D2RTI9KYH"
        ]
      }
    }
  ]
}