{"active_ingredient":["Active ingredient (in each caplet) Diphenhydramine HCl 25 mg"],"dosage_and_administration":["Directions adults and children 12 years and over take 2 caplets at bedtime if needed, or as directed by a doctor children under 12 years do not use"],"dosage_and_administration_table":["<table border=\"2\" width=\"50%\"><caption/><tbody><tr><td styleCode=\"Rrule Botrule\">adults and children 12 years and over</td><td styleCode=\"Rrule Botrule\">take 2 caplets at bedtime if needed, or as directed by a doctor</td></tr><tr><td styleCode=\"Rrule Botrule\">children under 12 years</td><td styleCode=\"Rrule Botrule\">do not use</td></tr></tbody></table>"],"effective_time":"20241029","id":"ded4acec-e3d4-42cd-a4ce-a6d2baff1c80","inactive_ingredient":["Inactive ingredients croscarmellose sodium, dicalcium phosphate, FD&C blue no. 1, FD&C blue no. 2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide"],"indications_and_usage":["Use • for relief of occasional sleeplessness"],"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":["M010"],"brand_name":["GOOD REMEDIES Nighttime Sleep Aid Caplets"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Strive Pharmaceuticals Inc."],"package_ndc":["70692-011-06"],"product_ndc":["70692-011"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049630"],"spl_id":["ded4acec-e3d4-42cd-a4ce-a6d2baff1c80"],"spl_set_id":["24fba735-cedf-9d15-e063-6394a90af873"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["Packaging GOOD REMEDIES SLEEP AID 70692-011-06"],"purpose":["Purpose Nighttime sleep aid"],"questions":["Questions or comments? 1-888-577-8033 Monday - Friday 8am - 4pm EST"],"set_id":"24fba735-cedf-9d15-e063-6394a90af873","spl_product_data_elements":["GOOD REMEDIES Nighttime Sleep Aid Caplets Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C BLUE NO. 1 FD&C BLUE NO. 2 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SILICON DIOXIDE TALC TITANIUM DIOXIDE DB"],"spl_unclassified_section":["Drug Facts","Compare to the active ingredient of TYLENOL PM® Simply Sleep®* Helps you fall asleep Safe, non-habit forming READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION *This product is not manufactured or distributed by Kenvue, Inc., owner of the registered trademarks Tylenol PM® and Simply Sleep®. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816 PRODUCT OF INDIA"],"storage_and_handling":["Other information • each caplet contains: calcium 22 mg • store at room temperature between 20°-25°C (68°-77°F) • protect from light, heat and moisture"],"version":"2","warnings":["Warnings Do not use • in children under 12 years of age • 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 • avoid alcoholic drinks • drowsiness will occur • do not drive a motor vehicle or operate machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. 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."]}