{"active_ingredient":["Drug Facts Active ingredient (in each tablet) Dimenhydrinate 50 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"],"dosage_and_administration":["Directions ■ to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity ■ adults and children 12 years of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor ■ children 6 to under 12 years of age: 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor ■ children 2 to under 6 years of age: 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor"],"effective_time":"20260220","id":"4b4343e5-4d4d-6a4a-e063-6394a90ad2bc","inactive_ingredient":["croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose"],"indications_and_usage":["Uses for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M009"],"brand_name":["Dimenhydrinate"],"generic_name":["DIMENHYDRINATE"],"is_original_packager":[true],"manufacturer_name":["LEADER/ Cardinal Health 110, Inc."],"package_ndc":["70000-0404-1"],"product_ndc":["70000-0404"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198603"],"spl_id":["4b4343e5-4d4d-6a4a-e063-6394a90ad2bc"],"spl_set_id":["7c4adbdb-9bce-0c9c-e053-2a91aa0a8107"],"substance_name":["DIMENHYDRINATE"],"unii":["JB937PER5C"],"upc":["0096295135183"]},"other_safety_information":["Other information ■ each tablet contains : calcium 30 mg ■ store in a dry place at 15° – 30°C (59° – 86°F) ■ protect from moisture ■ see end flap for expiration date and lot number ■ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN"],"overdosage":["In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"package_label_principal_display_panel":["LEADER NDC 7000-0404-1 Original Formula Motion Sickness Relief Dimenhydrinate, 50 mg/ Antiemetic COMPARE TO DRAMAMINE® ORIGINAL FORMULA active ingredient* Fast Acting Motion Sickness Relief for Children & Adults 12 Tablets Cardinal Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antiemetic"],"questions":["Questions or comments? 1-800-231-4670"],"set_id":"7c4adbdb-9bce-0c9c-e053-2a91aa0a8107","spl_product_data_elements":["Dimenhydrinate Dimenhydrinate CROSCARMELLOSE SODIUM CROSCARMELLOSE MAGNESIUM STEARATE DIBASIC CALCIUM PHOSPHATE DIHYDRATE DIMENHYDRINATE CHLORTHEOPHYLLINE MICROCRYSTALLINE CELLULOSE 1006;1006"],"spl_unclassified_section":["*This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine® KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION ©2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 All LEADER™ Brand Products Have A 100% Money Back Guarantee"],"version":"7","warnings":["Do not give to children under 2 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 ■ marked drowsiness may occur ■ avoid alcoholic drinks ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ 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 (1-800-222-1222) right away."],"when_using":["When using this product ■ marked drowsiness may occur ■ avoid alcoholic drinks ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ use caution when driving a motor vehicle or operating machinery"]}