{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
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  "results": [
    {
      "spl_product_data_elements": [
        "Meclizine Hydrochloride Meclizine Hydrochloride CROSPOVIDONE, UNSPECIFIED VANILLA MAGNESIUM STEARATE RASPBERRY STEARIC ACID SILICON DIOXIDE FD&C RED NO. 40 MECLIZINE HYDROCHLORIDE MECLIZINE LACTOSE MONOHYDRATE SACCHARIN SODIUM CROSCARMELLOSE SODIUM Rosy 5172"
      ],
      "active_ingredient": [
        "Drug Facts Active ingredient (in each chewable tablet) Meclizine HCl 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 for 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 a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product  drowsiness may occur  alcohol, sedatives, and tranquilizers may increase drowsiness  avoid alcoholic drinks  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 (1-800-222-1222)."
      ],
      "do_not_use": [
        "Do not use for children under 12 years of age unless directed by a doctor"
      ],
      "ask_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  drowsiness may occur  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."
      ],
      "overdosage": [
        "In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."
      ],
      "dosage_and_administration": [
        "Directions  Dosage should be taken one hour before travel starts adults and children 12 years of age and over chew 1 to 2 tablets once daily, or as directed by a doctor children under 12 years of age do not give to children under 12 years of age unless directed by a doctor"
      ],
      "dosage_and_administration_table": [
        "<table border=\"0\"><tbody><tr><td>adults and children 12   years of age and over </td><td>chew 1 to 2 tablets once daily, or as directed by a doctor</td></tr><tr><td>children under   12 years of age </td><td>do not give to children under 12 years of age   unless directed by a doctor </td></tr></tbody></table>"
      ],
      "other_safety_information": [
        "Other information  Store in a dry place at 15°-30°C (59°-86°F)  keep lid tightly closed"
      ],
      "inactive_ingredient": [
        "Inactive ingredients croscarmellose sodium, crospovidone, FD&C red #40 lake, french vanilla flavor, lactose, magnesium stearate, raspberry flavor, silica, sodium saccharin, stearic acid."
      ],
      "questions": [
        "Questions or comments? 1-800-231-4670"
      ],
      "spl_unclassified_section": [
        "TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation, owner of the registered trademark Bonine®. Distributed by: RUGBY® LABORATORIES Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Rev. 11/25 R-29 Re-order No. 371033"
      ],
      "how_supplied": [
        "HOW SUPPLIED Product: 50090-5496 NDC: 50090-5496-0 30 TABLET, CHEWABLE in a BOTTLE"
      ],
      "package_label_principal_display_panel": [
        "MECLIZINE HYDROCHLORIDE Label Image"
      ],
      "set_id": "2518b0b6-35ab-49f4-936c-1eafea04b466",
      "id": "92ab8dc3-a587-47ac-8e3a-dfc7ba794b6c",
      "effective_time": "20260909",
      "version": "8",
      "openfda": {
        "application_number": [
          "M009"
        ],
        "brand_name": [
          "Meclizine Hydrochloride"
        ],
        "generic_name": [
          "MECLIZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "A-S Medication Solutions"
        ],
        "product_ndc": [
          "50090-5496"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MECLIZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "995632"
        ],
        "spl_id": [
          "92ab8dc3-a587-47ac-8e3a-dfc7ba794b6c"
        ],
        "spl_set_id": [
          "2518b0b6-35ab-49f4-936c-1eafea04b466"
        ],
        "package_ndc": [
          "50090-5496-0"
        ],
        "original_packager_product_ndc": [
          "0536-1299"
        ],
        "unii": [
          "HDP7W44CIO"
        ]
      }
    }
  ]
}