{
  "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",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Curist Childrens Allergy Relief loratadine 5 mg chewable tablets ASPARTAME MANNITOL STEARIC ACID ANHYDROUS CITRIC ACID MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO MICROCRYSTALLINE CELLULOSE LORATADINE LORATADINE SILICON DIOXIDE white to off-white bevelled edge 106"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Keep the carton. It contains important information. See end panel for expiration date.",
        "REV: 031-43-01 NDC: 72559-031-43 Distributed by: Little Pharma, Inc. New York, NY 10023 Tableted and Packaged in USA"
      ],
      "active_ingredient": [
        "Active ingredient (in each chewable tablet) Loratadine USP, 5 mg"
      ],
      "purpose": [
        "Purpose Antihistamine"
      ],
      "indications_and_usage": [
        "Uses 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"
      ],
      "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": [
        "chew or crush tablets completely before swallowing. adults and children 6 years and over chew 2 tablets daily; not more than 2 chewable tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 chewable tablets 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>adults and children 6 years and over</td><td>chew 2 tablets daily; not more than 2 chewable tablets in 24 hours</td></tr><tr><td>children 2 to under 6 years of age</td><td>chew 1 tablet daily; not more than 1 chewable tablets in 24 hours</td></tr><tr><td>children under 2 years of age</td><td>ask a doctor</td></tr><tr><td>consumers with liver or kidney disease</td><td>ask a doctor</td></tr></tbody></table>"
      ],
      "storage_and_handling": [
        "Other information phenylketonurics: contains phenylalanine 1.25 mg per tablet. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. store between 20º to 25ºC (68º to 77ºF)."
      ],
      "inactive_ingredient": [
        "Inactive ingredients aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid"
      ],
      "questions": [
        "Questions? Call 1-844-243-1241 or email hi@curistrelief.com"
      ],
      "package_label_principal_display_panel": [
        "curist kids Children's Allergy Relief Loratadine Chewable Tablets USP, 5 mg Antihistamine Indoor and Outdoor Allergies 24 Hour Relief of Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose Non-Drowsy* 60 CHEWABLE TABLETS The chewable tablets are to be chewed before swallowing. AGES 2+ YEARS *When taken as directed. See Drug Facts Panel. Grape Flavored Dye-Free curistrelief.com Loratadine Chewable Image"
      ],
      "set_id": "1ab6a653-0b7c-69d7-e063-6394a90aacad",
      "id": "21427efa-5637-57cc-e063-6294a90aa354",
      "effective_time": "20240903",
      "version": "2",
      "openfda": {
        "application_number": [
          "ANDA210088"
        ],
        "brand_name": [
          "Curist Childrens Allergy Relief"
        ],
        "generic_name": [
          "LORATADINE 5 MG CHEWABLE TABLETS"
        ],
        "manufacturer_name": [
          "Little Pharma, Inc."
        ],
        "product_ndc": [
          "72559-031"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LORATADINE"
        ],
        "rxcui": [
          "665078"
        ],
        "spl_id": [
          "21427efa-5637-57cc-e063-6294a90aa354"
        ],
        "spl_set_id": [
          "1ab6a653-0b7c-69d7-e063-6394a90aacad"
        ],
        "package_ndc": [
          "72559-031-43"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "7AJO3BO7QN"
        ]
      }
    }
  ]
}