{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Texaclear Fast Acting Allergy Relief Chlophedianol Hydrochloride, Pyrilamine Maleate ANHYDROUS CITRIC ACID GLYCERIN PROPYLENE GLYCOL WATER SODIUM CITRATE SACCHARIN SODIUM SORBITOL CHLOPHEDIANOL HYDROCHLORIDE CHLOPHEDIANOL PYRILAMINE MALEATE PYRILAMINE"
      ],
      "spl_unclassified_section": [
        "(Chlophedianol HCI & Pyrilamine Maleate), solution GM Pharmaceuticals, Inc. Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredients (in each 30 mL) Chlophedianol HCl 25 mg Pyrilamine Maleate 50 mg"
      ],
      "purpose": [
        "Purpose Cough suppressant Antihistamine"
      ],
      "indications_and_usage": [
        "Uses ■ temporarily relieves these symptoms due to the common cold, hay fever or other upper respiratory allergies: ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes ■ cough due to minor throat and bronchial irritation"
      ],
      "warnings": [
        "Warnings Ask a doctor before use if you have ■ a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema ■ glaucoma ■ difficulty in urination due to enlargement of the prostate gland ■ a cough that occurs with too much phlegm (mucus) ■ a breathing problem such as emphysema or chronic bronchitis Ask a doctor before use if you are ■ taking sedative or tranquilizers When using this product ■ do not use more than directed ■ marked drowsiness may occur ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery ■ excitability may occur, especially in children Stop use and ask a doctor if ■ nervousness, dizziness, or sleeplessness occurs ■ symptoms do not improve within 7 days, tend to recur, or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. ■ new symptoms occur 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."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have ■ a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema ■ glaucoma ■ difficulty in urination due to enlargement of the prostate gland ■ a cough that occurs with too much phlegm (mucus) ■ a breathing problem such as emphysema or chronic bronchitis",
        "Ask a doctor before use if you are ■ taking sedative or tranquilizers"
      ],
      "when_using": [
        "When using this product ■ do not use more than directed ■ marked drowsiness may occur ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery ■ excitability may occur, especially in children"
      ],
      "stop_use": [
        "Stop use and ask a doctor if ■ nervousness, dizziness, or sleeplessness occurs ■ symptoms do not improve within 7 days, tend to recur, or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. ■ new symptoms occur"
      ],
      "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 exceed 4 doses in any 24 hour period ■ use enclosed dose cup and keep with product ■ mL= milliliter ■ adults and children 12 yrs and over: 30 mL every 6 to 8 hrs ■ children under 12 years of age: do not use"
      ],
      "other_safety_information": [
        "Other information ■ each 30 mL contains: Sodium 17 mg ■ read all product information before using ■ store at room temperature 20-30°C (68-86°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol"
      ],
      "questions": [
        "Questions or comments? Call 1-888-535-0305 9 a.m. - 5 p.m. CST."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL NDC 58809-360-08 TEXACLEAR FAST ACTING ALLERGY RELIEF 8 fl oz (237 mL) Texaclear PDP TexaClear Drug Facts"
      ],
      "set_id": "17a2f643-fa98-21ee-e054-00144ff88e88",
      "id": "42b3cfc3-8903-edc1-e063-6394a90aa6fe",
      "effective_time": "20251103",
      "version": "12",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Texaclear Fast Acting Allergy Relief"
        ],
        "generic_name": [
          "CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE"
        ],
        "manufacturer_name": [
          "GM Pharmaceuticals, INC"
        ],
        "product_ndc": [
          "58809-360"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CHLOPHEDIANOL HYDROCHLORIDE",
          "PYRILAMINE MALEATE"
        ],
        "rxcui": [
          "2672917"
        ],
        "spl_id": [
          "42b3cfc3-8903-edc1-e063-6394a90aa6fe"
        ],
        "spl_set_id": [
          "17a2f643-fa98-21ee-e054-00144ff88e88"
        ],
        "package_ndc": [
          "58809-360-08"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0358809360086"
        ],
        "unii": [
          "69QQ58998Y",
          "R35D29L3ZA"
        ]
      }
    }
  ]
}