{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Loratadine 10mg Loratadine 10mg MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN LORATADINE LORATADINE LACTOSE MONOHYDRATE (White to off white) G;10"
      ],
      "active_ingredient": [
        "Active ingredient (in each tablet) Loratadine 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": [
        "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."
      ],
      "dosage_and_administration": [
        "Directions adults and 1 tablet daily; not more than 1 tablet in 24 hours children 6 years and over children under ask a doctor 6 years of age consumers with ask a doctor liver or kidney disease"
      ],
      "storage_and_handling": [
        "Other information  Tamper evident: do not use if imprinted seal under cap, printed with \"SEALED FOR YOUR PROTECTION\" is missing, open or broken  store between 20° to 25°C (68° to 77°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized"
      ],
      "questions": [
        "Questions or comments? contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST"
      ],
      "package_label_principal_display_panel": [
        "PDP Loratadine 10mg"
      ],
      "set_id": "181b7dd1-ddc4-e799-e063-6294a90a9faa",
      "id": "4651ad94-6c6f-dda7-e063-6394a90adc73",
      "effective_time": "20251219",
      "version": "4",
      "openfda": {
        "application_number": [
          "ANDA210722"
        ],
        "brand_name": [
          "Loratadine 10mg"
        ],
        "generic_name": [
          "LORATADINE 10MG"
        ],
        "manufacturer_name": [
          "Meijer"
        ],
        "product_ndc": [
          "79481-7870"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LORATADINE"
        ],
        "rxcui": [
          "311372"
        ],
        "spl_id": [
          "4651ad94-6c6f-dda7-e063-6394a90adc73"
        ],
        "spl_set_id": [
          "181b7dd1-ddc4-e799-e063-6294a90a9faa"
        ],
        "package_ndc": [
          "79481-7870-3"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "7AJO3BO7QN"
        ]
      }
    }
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}