{
  "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",
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  "results": [
    {
      "spl_product_data_elements": [
        "Loratadine 10 mg Loratadine Tablets USP, 10 mg MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A SILICON DIOXIDE MICROCRYSTALLINE CELLULOSE 101 LACTOSE MONOHYDRATE LORATADINE LORATADINE White to off-white 92"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient (in each tablet) Loratadine USP, 10 mg"
      ],
      "purpose": [
        "Purpose Antihistamine"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat"
      ],
      "warnings": [
        "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. 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 (1-800-222-1222)."
      ],
      "do_not_use": [
        "Do not use if you have ever had an allergic reaction to this product or any of its ingredients."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose."
      ],
      "when_using": [
        "When using this product do not take more than directed. Taking more than directed may cause drowsiness"
      ],
      "stop_use": [
        "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."
      ],
      "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 (1-800-222-1222)."
      ],
      "dosage_and_administration": [
        "Directions adults and children 6 years and over: 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age: ask a doctor consumers with liver or kidney disease: ask a doctor"
      ],
      "storage_and_handling": [
        "Other information Tamper evident: do not use this product if the imprinted foil seal over the mouth of the bottle is cut, torn, broken or missing. store between 20º to 25º C (68º to 77º F) FDA approved dissolution test specifications differ from USP"
      ],
      "inactive_ingredient": [
        "Inactive ingredient colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate"
      ],
      "questions": [
        "Questions or comments? Call 1-877-290-4008"
      ],
      "package_label_principal_display_panel": [
        "loratadine-label-365s"
      ],
      "set_id": "2c80ea14-8490-4d26-e063-6294a90aecf0",
      "id": "2c80ea14-8491-4d26-e063-6294a90aecf0",
      "effective_time": "20250124",
      "version": "1",
      "openfda": {
        "application_number": [
          "ANDA219223"
        ],
        "brand_name": [
          "Loratadine 10 mg"
        ],
        "generic_name": [
          "LORATADINE TABLETS USP, 10 MG"
        ],
        "manufacturer_name": [
          "TIME CAP LABORATORIES, INC."
        ],
        "product_ndc": [
          "49483-732"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LORATADINE"
        ],
        "rxcui": [
          "311372"
        ],
        "spl_id": [
          "2c80ea14-8491-4d26-e063-6294a90aecf0"
        ],
        "spl_set_id": [
          "2c80ea14-8490-4d26-e063-6294a90aecf0"
        ],
        "package_ndc": [
          "49483-732-65"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0349483732658"
        ],
        "unii": [
          "7AJO3BO7QN"
        ]
      }
    }
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}