{
  "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": [
        "XL - 3 Allergy XL - 3 Allergy LORATADINE LORATADINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A G;10"
      ],
      "active_ingredient": [
        "Active ingredient(s) Loratadine 10mg"
      ],
      "purpose": [
        "Purpose Antihistamine"
      ],
      "indications_and_usage": [
        "Use(s) 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 if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away."
      ],
      "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 if an allergic reaction to this product occurs. Seek medical help right away."
      ],
      "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 accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away."
      ],
      "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"
      ],
      "spl_unclassified_section": [
        "Other information store between 20° to 25°C (68° to 77°F) protect from excessive moisture do not use if blister unit is torn or open"
      ],
      "inactive_ingredient": [
        "Inactive ingredients lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate"
      ],
      "questions": [
        "Questions/Comments Call 1-888-952-0050 Monday through Friday 9AM - 5PM"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel XL - 3 Allergy XL - 3 Allergy"
      ],
      "set_id": "059a6e72-888e-4cb3-8722-4c3acbd6b4b0",
      "id": "928e4434-6c15-4bf1-bcfd-1f56a17510ed",
      "effective_time": "20240410",
      "version": "1",
      "openfda": {
        "application_number": [
          "ANDA210722"
        ],
        "brand_name": [
          "XL - 3 Allergy"
        ],
        "generic_name": [
          "XL - 3 ALLERGY"
        ],
        "manufacturer_name": [
          "Selder, S.A. de C.V."
        ],
        "product_ndc": [
          "63654-415"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LORATADINE"
        ],
        "rxcui": [
          "311372"
        ],
        "spl_id": [
          "928e4434-6c15-4bf1-bcfd-1f56a17510ed"
        ],
        "spl_set_id": [
          "059a6e72-888e-4cb3-8722-4c3acbd6b4b0"
        ],
        "package_ndc": [
          "63654-415-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "7AJO3BO7QN"
        ]
      }
    }
  ]
}