{
  "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": [
        "Allergy Relief Cetirizine HCl 10 mg CETIRIZINE HYDROCHLORIDE CETIRIZINE BUTYLATED HYDROXYTOLUENE GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 SODIUM HYDROXIDE"
      ],
      "active_ingredient": [
        "Active ingredient (in each softgel) Cetirizine HCl 10 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 or to an antihistamine containing hydroxyzine Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when drivinga motor vehicle or operating machinery Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose."
      ],
      "ask_doctor_or_pharmacist": [
        "Ask doctor or pharmacist before use if you are taking sedatives or tranquilizers"
      ],
      "when_using": [
        "When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when drivinga motor vehicle or operating machinery"
      ],
      "stop_use": [
        "Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant 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 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: one 10mg tablet once daily; do not take more than one 10mg tablet in 24 hours. A 5mg product may be appropriate for less severe symptoms Adults 65 years and over: ask a doctor 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°C to 25°C (68°F to 77°F ) do not use if imprinted safety seal under cap is broken or missing",
        "Questions or Comments? Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST Manufactured for A&Z Pharmaceutical, Inc. Hauppauge, NY 11788"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients butylated hydroxytoluene, gelatin, glycerine, polyethylene glycol 400, purified water, sodium hydroxide, sorbitol sorbitan solution, white ink"
      ],
      "package_label_principal_display_panel": [
        "Package/Label Principal Display Panel Cetirizine HCl 10mg Softgels Cetirizine HCl 10mg Softgels"
      ],
      "set_id": "96952314-fd4c-455f-b55e-645c19d6e366",
      "id": "9dbab14c-2a68-408a-961c-6325df359d73",
      "effective_time": "20181231",
      "version": "1",
      "openfda": {
        "application_number": [
          "ANDA078317"
        ],
        "brand_name": [
          "Allergy Relief"
        ],
        "generic_name": [
          "CETIRIZINE HCL 10 MG"
        ],
        "manufacturer_name": [
          "Allegiant Health"
        ],
        "product_ndc": [
          "69168-392"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1014675"
        ],
        "spl_id": [
          "9dbab14c-2a68-408a-961c-6325df359d73"
        ],
        "spl_set_id": [
          "96952314-fd4c-455f-b55e-645c19d6e366"
        ],
        "package_ndc": [
          "69168-392-25"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0369168392250"
        ],
        "unii": [
          "64O047KTOA"
        ]
      }
    }
  ]
}