{
  "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": 4
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Meclizine HCl MECLIZINE HYDROCHLORIDE CHEWABLE ASPARTAME CROSCARMELLOSE SODIUM DEXTROSE, UNSPECIFIED FORM FD&C RED NO. 40 MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE RASPBERRY SILICON DIOXIDE SODIUM SULFATE ANHYDROUS SUCROSE TRIBASIC CALCIUM PHOSPHATE MECLIZINE HYDROCHLORIDE MECLIZINE Pink to light pink M"
      ],
      "active_ingredient": [
        "Drug Facts Active ingredient (in each chewable tablet) Meclizine HCl, USP 25 mg"
      ],
      "purpose": [
        "Purpose Antiemetic"
      ],
      "indications_and_usage": [
        "Uses prevents and treats nausea, vomiting or dizziness due to motion sickness."
      ],
      "warnings": [
        "Warnings Do not use in children under 12 years of age unless directed by a doctor Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers."
      ],
      "when_using": [
        "When using this product may cause drowsiness alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks use caution when driving a motor vehicle or operating machinery"
      ],
      "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 the Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Directions Dosage should be taken one hour before travel starts Adults and children 12 years and older: Chew 1-2 tablets once daily, or as directed by a doctor Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor"
      ],
      "storage_and_handling": [
        "Other Information Phenylketonurics: Contains Phenylalanine 0.0025 mg per tablet Store at room temperature in a dry place Keep lid tightly closed"
      ],
      "inactive_ingredient": [
        "Inactive ingredients aspartame, colloidal silicon dioxide, croscarmellose sodium, dextrose, lake of FD & C Red 40, magnesium stearate, maltodextrin, microcrystalline cellulose, raspberry flavor, sodium sulfate anhydrous, sucrose, tribasic calcium phosphate"
      ],
      "questions": [
        "Questions or comments? Call 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET"
      ],
      "spl_unclassified_section": [
        "TAMPER EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH\"SEALED for YOUR PROTECTION\" IS BROKEN OR MISSING. Rising Pharma Holdings, Inc. is not affiliated with the owner of the registered trademark Bonine® Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Mfg. Lic. No.: G/1430 Feb 2022"
      ],
      "how_supplied": [
        "HOW SUPPLIED NDC: 71335-9751-1: 30 Tablets in a BOTTLE NDC: 71335-9751-2: 20 Tablets in a BOTTLE NDC: 71335-9751-3: 25 Tablets in a BOTTLE NDC: 71335-9751-4: 40 Tablets in a BOTTLE NDC: 71335-9751-5: 60 Tablets in a BOTTLE NDC: 71335-9751-6: 90 Tablets in a BOTTLE NDC: 71335-9751-7: 8 Tablets in a BOTTLE NDC: 71335-9751-8: 14 Tablets in a BOTTLE NDC: 71335-9751-9: 10 Tablets in a BOTTLE NDC: 71335-9751-0: 120 Tablets in a BOTTLE"
      ],
      "package_label_principal_display_panel": [
        "Meclizine 25 mg Chewable Label"
      ],
      "set_id": "12446adb-0ff6-4f92-8bb2-b64b11d47e76",
      "id": "b5813836-d2ea-4aea-b894-fe428dd7e91d",
      "effective_time": "20241212",
      "version": "102",
      "openfda": {
        "application_number": [
          "M009.50"
        ],
        "brand_name": [
          "Meclizine HCl"
        ],
        "generic_name": [
          "MECLIZINE HYDROCHLORIDE CHEWABLE"
        ],
        "manufacturer_name": [
          "Bryant Ranch Prepack"
        ],
        "product_ndc": [
          "71335-9751"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MECLIZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "995632"
        ],
        "spl_id": [
          "b5813836-d2ea-4aea-b894-fe428dd7e91d"
        ],
        "spl_set_id": [
          "12446adb-0ff6-4f92-8bb2-b64b11d47e76"
        ],
        "package_ndc": [
          "71335-9751-1",
          "71335-9751-2",
          "71335-9751-3",
          "71335-9751-4",
          "71335-9751-5",
          "71335-9751-6",
          "71335-9751-7",
          "71335-9751-8",
          "71335-9751-9",
          "71335-9751-0"
        ],
        "original_packager_product_ndc": [
          "16571-824"
        ],
        "unii": [
          "HDP7W44CIO"
        ]
      }
    }
  ]
}