{"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 rst 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":"20250813","id":"3c44729b-0a55-8eaf-e063-6394a90a5ba4","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":["Major Pharmaceuticals"],"package_ndc":["0904-6772-12"],"product_ndc":["0904-6772"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198603"],"spl_id":["3c44729b-0a55-8eaf-e063-6394a90a5ba4"],"spl_set_id":["78d22836-a442-7c0c-e053-2991aa0a62f3"],"substance_name":["DIMENHYDRINATE"],"unii":["JB937PER5C"],"upc":["0309046772125"]},"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 -ap 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":["MAJOR ® NDC 0904-6772-12 Compare to the Active Ingredient in DRAMAMINE ® Original Formula* Driminate TM Dimenhydrinate USP, Antiemetic For Nausea, Dizziness and Vomiting from Motion Sickness 12 Tablets 50mg Each Use as Directed Major 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":"78d22836-a442-7c0c-e053-2991aa0a62f3","spl_product_data_elements":["Dimenhydrinate Dimenhydrinate DIMENHYDRINATE CHLORTHEOPHYLLINE CROSCARMELLOSE SODIUM CROSCARMELLOSE DIBASIC CALCIUM PHOSPHATE DIHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 1006;1006"],"spl_unclassified_section":["KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION *This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine®. Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 Questions or comments? Call (800) 616-2471 www.majorpharmaceuticals.com"],"version":"4","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"]}