{
  "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,
      "total": 101
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "All Day Allergy Cetirizine HCl CETIRIZINE HYDROCHLORIDE CETIRIZINE GELATIN ISOPROPYL ALCOHOL POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SODIUM HYDROXIDE SORBITAN SORBITOL SHELLAC SODIUM LAURYLSULFONATE TITANIUM DIOXIDE WATER MEDIUM-CHAIN TRIGLYCERIDES clear 291"
      ],
      "active_ingredient": [
        "Active Ingredient (in each capsule) Cetirizine HCl USP,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": [
        "Warning"
      ],
      "do_not_use": [
        "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_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 a doctor or pharmacist before use if you are taking tranquilizers or sedatives."
      ],
      "when_using": [
        "When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery"
      ],
      "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 if breast-feeding: not recommended if pregnant: 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 (1-800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 6 years and over One 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg 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"
      ],
      "dosage_and_administration_table": [
        "<table width=\"665px\"><col/><col/><tbody><tr><td>Adults and children 6 years and over</td><td>One 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms.</td></tr><tr><td>Adults 65 years and over</td><td> ask a doctor.</td></tr><tr><td>Children under 6 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 store at 20º -25ºC (68º - 77ºF) avoid high humidity and excessive heat above 40ºC (104ºF) protect from light"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients gelatin, medium chain triglyceride, polyethylene glycol 400, printing ink white, (isopropyl alcohol, propylene glycol, shellac resins, sodium lauryl sulphate, titanium dioxide) purified water, sodium hydroxide, sorbitan, sorbitol solution"
      ],
      "questions": [
        "Questions or comments? Call toll free:"
      ],
      "package_label_principal_display_panel": [
        "Principal display panel †Compare to the active ingredient in Zyrtec® Allergy Relief Cetirizine HCl CAPSULES, 10 mg Antihistamine INDOOR & OUTDOOR ALLERGIES 24-HOUR RELIEF OF: Sneezing Runny nose Itchy, watery eyes Itchy throat or nose LIQUID GELS** (**LIQUID FILLED CAPSULES) †This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Zyrtec®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147",
        "Product Label CARE ONE Allergy Relief Cetirizine HCl USP, 10 mg"
      ],
      "set_id": "01d0729f-11ef-4ec5-8d8e-2863407c3f95",
      "id": "67a5a75a-7a28-4d07-99b4-8325d1776f3a",
      "effective_time": "20250407",
      "version": "2",
      "openfda": {
        "application_number": [
          "ANDA205291"
        ],
        "brand_name": [
          "All Day Allergy"
        ],
        "generic_name": [
          "CETIRIZINE HCL"
        ],
        "manufacturer_name": [
          "Care One (American Sales Company)"
        ],
        "product_ndc": [
          "41520-212"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1014675"
        ],
        "spl_id": [
          "67a5a75a-7a28-4d07-99b4-8325d1776f3a"
        ],
        "spl_set_id": [
          "01d0729f-11ef-4ec5-8d8e-2863407c3f95"
        ],
        "package_ndc": [
          "41520-212-25"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0341520001239"
        ],
        "unii": [
          "64O047KTOA"
        ]
      }
    }
  ]
}