{
  "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": "2026-06-01",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "SPRINSOL Chlorpheniramine maleate SILICON DIOXIDE STARCH, CORN FD&C RED NO. 40 LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A POTATO CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE FORTUNE"
      ],
      "active_ingredient": [
        "Active ingredients (in each tablet) Chlorpheniramine maleate 4 mg"
      ],
      "purpose": [
        "Purpose Antihistamine"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: sneezing runny nose itching of the nose or throat itchy, watery eyes"
      ],
      "warnings": [
        "Warnings Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers"
      ],
      "when_using": [
        "When using this product do not exceed recommended dosage unless directed by a physician may cause excitability especially in children use caution when driving or operating machinery avoid alcoholic beverages may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect"
      ],
      "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 adults and children 12 years of age and over: take 1 tablet every 4 to 6 hours, not to exceed 6 tablets (24 mg) in 24 hours, or as directed by a doctor children under 12 years of age: consult a doctor"
      ],
      "other_safety_information": [
        "Other information keep tightly sealed protect from light store between 20 to 25 C (68 to 77 F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients colloidal silicon dioxide, corn starch, FD C red no. 40 aluminum lake, lactose monohydrate, magnesium stearate, povidone K30, sodium starch glycolate"
      ],
      "questions": [
        "Questions or comments? (888) 221-3496 M-F 9 am to 5 pm you may also report serious side effects to this phone number"
      ],
      "package_label_principal_display_panel": [
        "Sprinsol Safely Sealed NDC 51467-101-02 Chlorpheniramine maleate - Antihistamine temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: sneezing runny nose itching of the nose or throat itchy, watery eyes 36 Tablets In Individually Sealed Strip Respiratory Series IMAGE OF CARTON"
      ],
      "set_id": "01a1a91e-04ba-4526-8946-10483932b30c",
      "id": "43810cbb-1d34-d1ff-e063-6294a90a2b40",
      "effective_time": "20251113",
      "version": "3",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "SPRINSOL"
        ],
        "generic_name": [
          "CHLORPHENIRAMINE MALEATE"
        ],
        "manufacturer_name": [
          "FORTUNE PHARMACAL COMPANY LIMITED"
        ],
        "product_ndc": [
          "51467-101"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CHLORPHENIRAMINE MALEATE"
        ],
        "rxcui": [
          "1363309"
        ],
        "spl_id": [
          "43810cbb-1d34-d1ff-e063-6294a90a2b40"
        ],
        "spl_set_id": [
          "01a1a91e-04ba-4526-8946-10483932b30c"
        ],
        "package_ndc": [
          "51467-101-01",
          "51467-101-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "V1Q0O9OJ9Z"
        ]
      }
    }
  ]
}