{"active_ingredient":["Active ingredient (in each tablet) Diphenhydramine HCl 25 mg"],"dosage_and_administration":["Directions • take every 4 to 6 hours, or as directed by doctor • do not take more than 6 times in 24 hours adults and children 12 years and older 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years old do not use"],"dosage_and_administration_table":["<table width=\"50%\"><tbody><tr><td styleCode=\"Botrule Rrule\"> adults and children 12 years and older</td><td styleCode=\"Botrule\" align=\"right\"> 1 to 2 tablets</td></tr><tr><td styleCode=\"Botrule Rrule\"> children 6 to under 12 years</td><td styleCode=\"Botrule\" align=\"right\"> 1 tablet</td></tr><tr><td styleCode=\"Botrule Rrule\"> children under 6 years old</td><td styleCode=\"Botrule\" align=\"right\"> do not use</td></tr></tbody></table>"],"effective_time":"20241211","id":"ec06fc1c-c111-4d17-b42f-9817a45bf385","inactive_ingredient":["Inactive ingredients croscarmellose sodium, dicalcium phosphate, D&C red #27, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide"],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat temporarily relieves these symptoms due to the common cold: • runny nose • sneezing"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["Diphenhydramine Hydrochloride 25mg"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE 25MG"],"is_original_packager":[true],"manufacturer_name":["Strive Pharmaceuticals Inc"],"package_ndc":["70692-148-01","70692-148-46","70692-148-40","70692-148-62","70692-148-11"],"product_ndc":["70692-148"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049630"],"spl_id":["ec06fc1c-c111-4d17-b42f-9817a45bf385"],"spl_set_id":["b440eb2e-4de9-2b65-e053-2995a90abda8"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0370692136012","0370692000245"]},"package_label_principal_display_panel":["Packaging Strive-148-1 Strive-148-2"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-888-577-8033 Monday-Friday 8am-4pm EST"],"set_id":"b440eb2e-4de9-2b65-e053-2995a90abda8","spl_product_data_elements":["Diphenhydramine Hydrochloride 25mg Diphenhydramine hydrochloride 25mg DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CROSCARMELLOSE SODIUM POLYVINYL ALCOHOL, UNSPECIFIED TALC POLYETHYLENE GLYCOL, UNSPECIFIED MAGNESIUM STEARATE TITANIUM DIOXIDE SILICON DIOXIDE MICROCRYSTALLINE CELLULOSE D&C RED NO. 27 ANHYDROUS DIBASIC CALCIUM PHOSPHATE DP"],"spl_unclassified_section":["Drug Facts","RIGHT REMEDIES Compare to the active ingredient of Benadryl ® Allergy ULTRATAB ®* *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl ® Allergy ULTRATAB ® Distributed by: Strive Pharmaceuticals Inc. East Brunswick, NJ 08816 Product of India Packaged and Quality Assured in the USA TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING"],"storage_and_handling":["Other information • each tablet contains: calcium 18.64 mg • store between 20-25°C (68-77°F) • protect from light."],"version":"5","warnings":["Warnings Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin 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 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 • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."]}