{"active_ingredient":["Drug Facts Active ingredient (in each chewable tablet) Meclizine HCl 25 mg"],"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"],"do_not_use":["Do not use in children under 12 years of age unless directed by a doctor"],"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 this product to children under 12 years of age unless directed by a doctor"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><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 this product to children under 12 years of age   unless directed by a doctor </td></tr></tbody></table>"],"effective_time":"20240610","id":"1a8bdae4-1b42-0a1c-e063-6294a90a49aa","inactive_ingredient":["Croscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, French Vanilla Flavor, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid"],"indications_and_usage":["Uses prevents and treats nausea, vomiting or dizziness due to motion sickness"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M009"],"brand_name":["Meclizine Hydrochloride"],"generic_name":["MECLIZINE HYDROCHLORIDE"],"manufacturer_name":["Aphena Pharma Solutions - Tennessee, LLC"],"original_packager_product_ndc":["0536-1299"],"package_ndc":["71610-836-30","71610-836-53","71610-836-60","71610-836-80"],"product_ndc":["71610-836"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["995632"],"spl_id":["1a8bdae4-1b42-0a1c-e063-6294a90a49aa"],"spl_set_id":["199ae195-4556-ee88-e063-6394a90a40d4"],"substance_name":["MECLIZINE HYDROCHLORIDE"],"unii":["HDP7W44CIO"]},"other_safety_information":["Other information  Store in a dry place at 15°-30°C (59°-86°F)  keep lid tightly closed"],"overdosage":["In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 25mg NDC 71610-836 - Meclizine 25mg Tablets - Rx Only Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antiemetic"],"questions":["Questions or comments? 1-800-645-2158"],"set_id":"199ae195-4556-ee88-e063-6394a90a40d4","spl_product_data_elements":["Meclizine Hydrochloride Meclizine Hydrochloride CROSPOVIDONE VANILLA MAGNESIUM STEARATE RASPBERRY STEARIC ACID SILICON DIOXIDE FD&C RED NO. 40 LACTOSE MONOHYDRATE SACCHARIN SODIUM CROSCARMELLOSE SODIUM MECLIZINE HYDROCHLORIDE MECLIZINE Rosy 5172"],"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 www.rugbylaboratories.com","REPACKAGING INFORMATION Please reference the HOW SUPPLIED section listed above for a description of individual drug products listed below. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC 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: 25mg NDC 71610-836-30, Bottles of 30 Tablets NDC 71610-836-53, Bottles of 60 Tablets NDC 71610-836-60, Bottles of 90 Tablets NDC 71610-836-80, Bottles of 180 Tablets 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 20240529AMH Aphena"],"version":"2","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 a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product  Do not exceed recommended dosage  may cause drowsiness  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)."],"when_using":["When using this product  Do not exceed recommended dosage  may cause drowsiness  alcohol, sedatives, and tranquilizers may increase drowsiness  avoid alcoholic drinks  use caution when driving a motor vehicle or operating machinery"]}