{
  "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": "2026-10-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "POLY-HIST DM DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR PROPYLPARABEN POTASSIUM CITRATE CITRIC ACID WATER SUCRALOSE PROPYLENE GLYCOL SORBITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DEXCHLORPHENIRAMINE MALEATE DEXCHLORPHENIRAMINE METHYLPARABEN"
      ],
      "active_ingredient": [
        "Active Ingredients (in each 5mL teaspoonful) Dexchlorpheniramine Maleate: 1mg Dextromethorphan HBr: 10mg"
      ],
      "indications_and_usage": [
        "Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat and bronchial irritation runny nose sneezing itching of nose or throat itchy, watery eyes"
      ],
      "warnings": [
        "Do not use this product 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 a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland heart disease high blood pressure thyroid disease diabetes Ask a doctor of pharmacist before use if you are taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. nervousness, dizziness, or sleeplessness occur new symptoms occur If pregnant or breast-feeding, ask a health professional before use."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 12 years of age and over: 2 teaspoonfuls (10mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1 teaspoonful (5mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Bubblegum Flavor, Citric Acid, Magnasweet, Methy Paraben, Potassium Citrate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol, Sucralose."
      ],
      "questions": [
        "Questions? Comments? Call 1-800-882-1041 Manufactured for: Poly Pharmaceuticals Huntsville, AL 35763"
      ],
      "purpose": [
        "Antihistamine Cough Suppressant"
      ],
      "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."
      ],
      "package_label_principal_display_panel": [
        "POLY-HIST DM"
      ],
      "set_id": "5025c99f-b946-e2e0-e063-6394a90a13fb",
      "id": "5025c99f-b947-e2e0-e063-6394a90a13fb",
      "effective_time": "20260423",
      "version": "1",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "POLY-HIST DM"
        ],
        "generic_name": [
          "DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR"
        ],
        "manufacturer_name": [
          "POLY PHARMACEUTICALS, INC."
        ],
        "product_ndc": [
          "50991-271"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "DEXCHLORPHENIRAMINE MALEATE"
        ],
        "rxcui": [
          "2741371"
        ],
        "spl_id": [
          "5025c99f-b947-e2e0-e063-6394a90a13fb"
        ],
        "spl_set_id": [
          "5025c99f-b946-e2e0-e063-6394a90a13fb"
        ],
        "package_ndc": [
          "50991-271-16",
          "50991-271-15"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0350991271164"
        ],
        "unii": [
          "9D2RTI9KYH",
          "B10YD955QW"
        ]
      }
    }
  ]
}