{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 141
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Meclizine HCL Meclizine HCl 25mg Chewable Tablets ASPARTAME CROSCARMELLOSE SODIUM DEXTROSE FD&C RED NO. 40 RASPBERRY MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SUCROSE MECLIZINE HYDROCHLORIDE MECLIZINE AP;115"
      ],
      "active_ingredient": [
        "Active ingredient Meclizine Hydrochloride 25 mg"
      ],
      "purpose": [
        "Purpose Antiemetic"
      ],
      "indications_and_usage": [
        "Uses For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness. For other uses consult your doctor"
      ],
      "warnings": [
        "Warnings Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an elarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product you may get drowsy avoid alcoholic drinks alcohol, sedatives and tranquilizers may increse drowsiness be careful when driving a moor vehicle or operating machinery"
      ],
      "dosage_and_administration": [
        "Directions take dose one hour before travel starts tablets can be chewed or swallowed whole with water adults & children 12 years and over: take 1-2 tablets once daily children under 12 years: ask a doctor"
      ],
      "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."
      ],
      "other_safety_information": [
        "OTHER INFORMATION Phenylketonurics: each tablet contains: phenylalanine 0.28 mg store at room temparature 15 - 30 °C"
      ],
      "questions": [
        "Questions or Comments Call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red 40 (al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor"
      ],
      "spl_unclassified_section": [
        "Repackaging Information Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 25 mg 30 71610-0528-30 90 71610-0528-60 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20210415JH Aphena Pharma Solutions - TN"
      ],
      "spl_unclassified_section_table": [
        "<table border=\"0\" cellpadding=\"1\" cellspacing=\"1\" width=\"28%\"><col width=\"10%\"/><col/><tbody><tr styleCode=\"Toprule\"><td align=\"center\" styleCode=\"bold\" valign=\"bottom\">Count</td><td align=\"center\" valign=\"bottom\"><content styleCode=\"bold\">25 mg</content></td></tr><tr><td align=\"center\" valign=\"bottom\">30</td><td align=\"center\">71610-0528-30</td></tr><tr><td align=\"center\" valign=\"bottom\">90</td><td align=\"center\">71610-0528-60</td></tr></tbody></table>"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 25 mg NDC 71610-528 - Meclizine HCl 25 mg Chewable Tablets Bottle Label 25 mg"
      ],
      "set_id": "02d1af4d-d97d-4019-a5bf-3ec391238676",
      "id": "2b4cfbd3-496d-100d-e063-6294a90aba52",
      "effective_time": "20250109",
      "version": "2",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Meclizine HCL"
        ],
        "generic_name": [
          "MECLIZINE HCL 25MG CHEWABLE TABLETS"
        ],
        "manufacturer_name": [
          "Aphena Pharma Solutions - Tennessee, LLC"
        ],
        "product_ndc": [
          "71610-528"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MECLIZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "995632"
        ],
        "spl_id": [
          "2b4cfbd3-496d-100d-e063-6294a90aba52"
        ],
        "spl_set_id": [
          "02d1af4d-d97d-4019-a5bf-3ec391238676"
        ],
        "package_ndc": [
          "71610-528-30",
          "71610-528-60"
        ],
        "original_packager_product_ndc": [
          "54738-025"
        ],
        "unii": [
          "HDP7W44CIO"
        ]
      }
    }
  ]
}