{
  "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": "2026-10-14",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Claritin loratadine SILICON DIOXIDE MAGNESIUM STEARATE MANNITOL CELLULOSE, MICROCRYSTALLINE STEARIC ACID LORATADINE LORATADINE ASPARTAME Light to Medium Pink with a Slightly and/or Mottled Appearance Round (Flat Faced Beveled Edge) C"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredients Loratadine 5 mg"
      ],
      "purpose": [
        "Purpose Antihistamine"
      ],
      "indications_and_usage": [
        "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat"
      ],
      "do_not_use": [
        "Do Not Use Do not use if you have ever had an allergic reaction to this product or any of its ingredients."
      ],
      "ask_doctor": [
        "AS a doctor before use if you have 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 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 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 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 6 years and over chew 2 tablets daily; not more than 2 tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 tablet in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor"
      ],
      "dosage_and_administration_table": [
        "<table border=\"0\" width=\"100%\"><tbody><tr><td><paragraph>adults and children 6 years and over</paragraph></td><td><paragraph>chew 2 tablets daily; not more than 2 tablets in 24 hours</paragraph></td></tr><tr><td><paragraph>children 2 to under 6 years of age </paragraph></td><td>chew 1 tablet daily; not more than 1 tablet in 24 hours</td></tr><tr><td>children under 2 years of age</td><td><paragraph>ask a doctor</paragraph></td></tr><tr><td>consumers with liver or kidney disease</td><td><paragraph>ask a doctor</paragraph></td></tr></tbody></table>"
      ],
      "other_safety_information": [
        "Other information phenylketonurics: contains phenylalanine 1.9 mg per tablet safety sealed: do not use if the individual blister unit imprinted with Children’s Claritin® is open or torn store between 20° to 25°C (68° to 77°F)"
      ],
      "inactive_ingredient": [
        "aspartame, carmine, citric acid, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid"
      ],
      "questions": [
        "1-800-CLARITIN"
      ],
      "warnings": [
        ""
      ],
      "package_label_principal_display_panel": [
        "ages 2 years® and older Children's Claritin® Chewables loratadine 5 mg/antihistamine Indoor & Outdoor Allergies *When taken as directed. See Drug Facts Panel Non-Drowsy* 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Bubblegum Flavored 10 Chewable Tablets 10-count carton"
      ],
      "set_id": "20938e05-bc3e-51aa-e054-00144ff88e88",
      "id": "45370735-3f9c-a7f8-e063-6294a90aa0c6",
      "effective_time": "20251205",
      "version": "8",
      "openfda": {
        "application_number": [
          "NDA021891"
        ],
        "brand_name": [
          "Claritin"
        ],
        "generic_name": [
          "LORATADINE"
        ],
        "manufacturer_name": [
          "Bayer HealthCare LLC."
        ],
        "product_ndc": [
          "11523-4330"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LORATADINE"
        ],
        "rxcui": [
          "665078",
          "668469"
        ],
        "spl_id": [
          "45370735-3f9c-a7f8-e063-6294a90aa0c6"
        ],
        "spl_set_id": [
          "20938e05-bc3e-51aa-e054-00144ff88e88"
        ],
        "package_ndc": [
          "11523-4330-1",
          "11523-4330-3",
          "11523-4330-4"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0041100811127"
        ],
        "unii": [
          "7AJO3BO7QN"
        ]
      }
    }
  ]
}