{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "BONINE meclizine hydrochloride MECLIZINE HYDROCHLORIDE MECLIZINE LACTOSE MONOHYDRATE FD&C RED NO. 40 SACCHARIN SODIUM STARCH, CORN MAGNESIUM STEARATE SILICON DIOXIDE BONINE"
      ],
      "active_ingredient": [
        "Active ingredient (in each tablet) Meclizine HCl 25 mg"
      ],
      "purpose": [
        "Purpose Antiemetic"
      ],
      "indications_and_usage": [
        "Uses prevents and treats nausea, vomiting or dizziness associated with 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 difficulty in urination due to enlargement of the prostate gland glaucoma a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness drowsiness may occur use caution when driving a motor vehicle or operating machinery 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."
      ],
      "do_not_use": [
        "Do not use in children under 12 years of age unless directed by a doctor."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have difficulty in urination due to enlargement of the prostate gland glaucoma a breathing problem such as emphysema or chronic bronchitis"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers."
      ],
      "when_using": [
        "When using this product avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness drowsiness may occur 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 a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions dosage should be taken one hour before travel starts chew or crush tablets completely before swallowing; do not swallow tablets whole adults and children 12 years and over: take 1 to 2 chewable tablets once daily or as directed by a doctor"
      ],
      "storage_and_handling": [
        "Other information store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F) see end flap for expiration date and lot number protect from heat and humidity"
      ],
      "inactive_ingredient": [
        "Inactive ingredients colloidal silicon dioxide, dextrose, FD&C red #40 aluminum lake, flavor, lactose monohydrate, magnesium stearate, pregelatinized starch, propylene glycol, saccharin sodium, silicon dioxide"
      ],
      "questions": [
        "Questions or comments? 1 (844) 241-5454 or www.bonine.com"
      ],
      "spl_unclassified_section": [
        "Dist. by: WellSpring Pharmaceutical Corporation Sarasota, FL 34243 ©2025 WellSpring Pharmaceutical Corporation TAMPER EVIDENT: DO NOT USE IF PRINTED TEAR STRIP IS BROKEN OR MISSING MONEY BACK GUARANTEE"
      ],
      "package_label_principal_display_panel": [
        "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 65197-297 TRAVEL SIZE Less drowsy vs. Dramamine® dimenhydrinate. Dramamine® is a registered trademark of Medtech Products Inc. 9X the Adventure** Meclizine HCl • Antiemetic 25 mg bonine 12ct bonine 12 ct Carton Back CT029512RF Carton 12 Front"
      ],
      "set_id": "0b2ea6b8-b342-4940-8922-898758fbeb31",
      "id": "9e33d2ae-5059-4214-b50f-fa5731f6f9ed",
      "effective_time": "20250321",
      "version": "2",
      "openfda": {
        "application_number": [
          "M009"
        ],
        "brand_name": [
          "BONINE"
        ],
        "generic_name": [
          "MECLIZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "WellSpring Pharmaceutical Corporation"
        ],
        "product_ndc": [
          "65197-297"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MECLIZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "995632",
          "995634"
        ],
        "spl_id": [
          "9e33d2ae-5059-4214-b50f-fa5731f6f9ed"
        ],
        "spl_set_id": [
          "0b2ea6b8-b342-4940-8922-898758fbeb31"
        ],
        "package_ndc": [
          "65197-297-08",
          "65197-297-12",
          "65197-297-16",
          "65197-297-24",
          "65197-297-48"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0365197275120"
        ],
        "unii": [
          "HDP7W44CIO"
        ]
      }
    }
  ]
}