{ "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, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Dramamine Orange Dimenhydrinate DIMENHYDRINATE 8-CHLOROTHEOPHYLLINE ANHYDROUS CITRIC ACID ASPARTAME FD&C YELLOW NO. 6 ALUMINUM OXIDE MAGNESIUM STEARATE MALTODEXTRIN SORBITOL" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredient (in each tablet) Dimenhydrinate 50 mg" ], "purpose": [ "Purpose Antiemetic" ], "indications_and_usage": [ "Use for prevention and treatment of these symptoms associated with motion sickness nausea vomiting dizziness" ], "warnings": [ "Warnings Do not give to children under 2 years of age unless directed by a doctor Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a d octor 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 be careful when driving a motor vehicle or operating machinery I f pregnant or breast-feeding, ask a doctor before use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "do_not_use": [ "Do not give to children under 2 years of age unless directed by a doctor" ], "ask_doctor": [ "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland" ], "ask_doctor_or_pharmacist": [ "Ask a d octor or pharmacist before use if you are taking sedatives or tranquilizers" ], "when_using": [ "When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "pregnancy_or_breast_feeding": [ "I f pregnant or breast-feeding, ask a doctor before use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "dosage_and_administration": [ "Directions to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity to prevent or treat motion sickness, see below: Adults and children 12 years and over take 1 to 2 tablets every 4-6 hours do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor Children 6 to under 12 years give ½ to 1 tablet every 6-8 hours do not give more than 3 chewable tablets in 24 hours, or as directed by a doctor Children 2 to under 6 years give ½ tablet every 6-8 hours do not give more than 1 ½ chewable tablets in 24 hours, or as directed by a doctor" ], "dosage_and_administration_table": [ "
Adults and children 12 years and over take 1 to 2 tablets every 4-6 hours do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years give ½ to 1 tablet every 6-8 hours do not give more than 3 chewable tablets in 24 hours, or as directed by a doctor
Children 2 to under 6 years give ½ tablet every 6-8 hours do not give more than 1 ½ chewable tablets in 24 hours, or as directed by a doctor
" ], "other_safety_information": [ "Other information Phenylketonurics: contains phenylalanine 0.84 mg per tablet store at room temperature 68-77ºF (20-25ºC) do not use if carton is opened or if blister is broken or torn see side panel for lot number and expiration date" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, aspartame, FD&C yellow #6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol" ], "questions": [ "Questions or comments? Call 1-800-382-7219" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Dimenhydrinate Tablets/Antiemetic CHEWABLE FORMULA Dramamine ® MOTION SICKNESS RELIEF DUAL ACTION 1. TREATS SYMPTOMS ON THE SPOT 2. PREVENTS NAUSEA, DIZZINESS & VOMITING Convenient Chewable Tablets 8 ORANGE FLAVORED TABLETS (50 mg EACH) PRINCIPAL DISPLAY PANEL Dimenhydrinate Tablets/Antiemetic CHEWABLE FORMULA Dramamine® MOTION SICKNESS RELIEF DUAL ACTION 1. TREATS SYMPTOMS ON THE SPOT 2. PREVENTS NAUSEA, DIZZINESS & VOMITING Conven", "PRINCIPAL DISPLAY PANEL Dimenhydrinate Tablets/Antiemetic CHEWABLE FORMULA Dramamine ® MOTION SICKNESS RELIEF DUAL ACTION 1. TREATS SYMPTOMS ON THE SPOT 2. PREVENTS NAUSEA, DIZZINESS & VOMITING Convenient Chewable Tablets 2 ORANGE FLAVORED TABLETS (50 mg EACH) PRINCIPAL DISPLAY PANEL Dimenhydrinate Tablets/Antiemetic CHEWABLE FORMULA Dramamine® MOTION SICKNESS RELIEF DUAL ACTION 1. TREATS SYMPTOMS ON THE SPOT 2. PREVENTS NAUSEA, DIZZINESS & VOMITING Conven" ], "set_id": "76166156-bce1-492f-833e-6bbd07859c3f", "id": "5bb5061c-c75c-0d41-e063-6294a90a2c59", "effective_time": "20260917", "version": "7", "openfda": { "application_number": [ "M009" ], "brand_name": [ "Dramamine Orange" ], "generic_name": [ "DIMENHYDRINATE" ], "manufacturer_name": [ "Medtech Products Inc." ], "product_ndc": [ "63029-902" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DIMENHYDRINATE" ], "rxcui": [ "309913", "602223" ], "spl_id": [ "5bb5061c-c75c-0d41-e063-6294a90a2c59" ], "spl_set_id": [ "76166156-bce1-492f-833e-6bbd07859c3f" ], "package_ndc": [ "63029-902-01", "63029-902-02", "63029-902-04" ], "is_original_packager": [ true ], "unii": [ "JB937PER5C" ] } } ] }