{
  "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": "2026-08-11",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Duratuss AC Codeine Phosphate, Dexbrompheniramine Maleate GLYCERIN ANHYDROUS CITRIC ACID SORBITOL WATER CODEINE PHOSPHATE CODEINE ANHYDROUS METHYLPARABEN PROPYLENE GLYCOL SUCRALOSE SODIUM CITRATE SODIUM BENZOATE DEXBROMPHENIRAMINE MALEATE DEXBROMPHENIRAMINE dye free, sugar free"
      ],
      "active_ingredient": [
        "Active ingredients (in each 5 mL teaspoonful) Codeine Phosphate 10 mg ................................................... Antitussive Dexbrompheniramine Maleate 1 mg ................................. Antihistamine"
      ],
      "purpose": [
        "Antihistamine Antitussive"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages"
      ],
      "warnings": [
        "Warnings Do not exceed recommended dosage."
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to the enlargement of the prostate gland a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm a chronic pulmonary disease or shortness of breath, or children who are taking other drugs heart disease high blood pressure thyroid disease diabetes"
      ],
      "when_using": [
        "When using this product excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks may cause or aggravate constipation alcohol, sedatives, and tranquilizers may increase drowsiness effect"
      ],
      "stop_use": [
        "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for 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. new symptoms occur"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breastfeeding 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"
      ],
      "do_not_use": [
        "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."
      ],
      "dosage_and_administration": [
        "Directions Adults 12 and over: 10 mL every 4-6 hours Not to exceed 60 mL in 24 hours or as directed by a doctor Children 6-12: 5 mL every 4 hours, Not to exceed 30 mL in 24 hrs or as directed by a doctor Children under 6: Consult a doctor"
      ],
      "other_safety_information": [
        "Other information Store at room temperature 15°C-30°C (59°F-86°F) Questions? Comments? Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041 Mon. - Fri. (8 a.m. to 5 p.m. CST)."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Inactive ingredients Cherry flavor, citric acid, glycerin, propylene glycol, purified water,sodium benzoate, sodium citrate, sorbitol solution, sucralose."
      ],
      "package_label_principal_display_panel": [
        "label"
      ],
      "set_id": "3e5ed178-d5d9-b8d4-e063-6394a90a91db",
      "id": "3e5ed178-d5d8-b8d4-e063-6394a90a91db",
      "effective_time": "20250909",
      "version": "1",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Duratuss AC"
        ],
        "generic_name": [
          "CODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATE"
        ],
        "manufacturer_name": [
          "Poly Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "50991-540"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CODEINE PHOSPHATE",
          "DEXBROMPHENIRAMINE MALEATE"
        ],
        "rxcui": [
          "2727418"
        ],
        "spl_id": [
          "3e5ed178-d5d8-b8d4-e063-6394a90a91db"
        ],
        "spl_set_id": [
          "3e5ed178-d5d9-b8d4-e063-6394a90a91db"
        ],
        "package_ndc": [
          "50991-540-16",
          "50991-540-20"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "GSL05Y1MN6",
          "BPA9UT29BS"
        ]
      }
    }
  ]
}