{ "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": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 34 } }, "results": [ { "spl_product_data_elements": [ "Motion Sickness Relief Dimenhydrinate DIMENHYDRINATE DIPHENHYDRAMINE 8-CHLOROTHEOPHYLLINE CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE STEARIC ACID 44;198" ], "active_ingredient": [ "Active ingredient (in each tablet) Dimenhydrinate 50 mg" ], "purpose": [ "Purpose Antiemetic" ], "indications_and_usage": [ "Uses for prevention and treatment of these symptoms associated with motion sickness: nausea vomiting dizziness" ], "warnings": [ "Warnings Do not use for 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 difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages 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." ], "do_not_use": [ "Do not use for 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 difficulty in urination due to enlargement of the 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 marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages" ], "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. In case of overdose, get medical help or contact a Poison Control Center right away." ], "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 and over 1 to 2 tablets every 4-6 hours; do not exceed 8 tablets in 24 hours, or as directed by a doctor children 6 to under 12 years 1/2 to 1 tablet every 6-8 hours; do not exceed 3 tablets in 24 hours, or as directed by a doctor children 2 to under 6 years 1/2 tablet every 6-8 hours; do not exceed 1&1/2 tablets in 24 hours, or as directed by a doctor" ], "dosage_and_administration_table": [ "
adults and children 12 years and over1 to 2 tablets every 4-6 hours; do not exceed 8 tablets in 24 hours, or as directed by a doctor
children 6 to under 12 years1/2 to 1 tablet every 6-8 hours; do not exceed 3 tablets in 24 hours, or as directed by a doctor
children 2 to under 6 years1/2 tablet every 6-8 hours; do not exceed 1&1/2 tablets in 24 hours, or as directed by a doctor
" ], "storage_and_handling": [ "Other information each tablet contains: calcium 35 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from moisture see end flap for expiration date and lot number" ], "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid" ], "questions": [ "Questions or comments? 1-800-426-9391" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 83324-032-12 QC® QUALITY CHOICE *Compare to the Active Ingredient in Dramamine® Original Formula Motion Sickness Relief Original Formula Dimenhydrinate 50 mg | Antiemetic Prevents: Nausea, Vomiting & Dizziness for Children & Adults 12 Tablets actual size TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine® Original Formula. 50844 REV0518A19802 SATISFACTION GUARANTEED 100% QC Distributed by CDMA, Inc. Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 Quality_Chocie_44-198 Quality_Chocie_44-198" ], "set_id": "00a327c6-6b86-4702-8c04-55c405c1404c", "id": "f4abe759-9295-4fc5-8af3-bd322c3fb338", "effective_time": "20260507", "version": "5", "openfda": { "application_number": [ "M009" ], "brand_name": [ "Motion Sickness Relief" ], "generic_name": [ "DIMENHYDRINATE" ], "manufacturer_name": [ "Chain Drug Marketing Association, Inc." ], "product_ndc": [ "83324-032" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DIMENHYDRINATE" ], "rxcui": [ "198603" ], "spl_id": [ "f4abe759-9295-4fc5-8af3-bd322c3fb338" ], "spl_set_id": [ "00a327c6-6b86-4702-8c04-55c405c1404c" ], "package_ndc": [ "83324-032-12", "83324-032-24" ], "is_original_packager": [ true ], "upc": [ "0635515997134" ], "unii": [ "JB937PER5C" ] } } ] }