{"active_ingredient":["Active ingredient (in each softgel) Diphenhydramine HCl 50 mg"],"dosage_and_administration":["Directions • adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor"],"effective_time":"20241231","id":"fcc77456-2add-4ebd-be0f-e744101db96e","inactive_ingredient":["Inactive ingredients FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, 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."],"openfda":{"application_number":["M010"],"brand_name":["Sleep Aid Nighttime"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["TOPCO ASSOCIATES LLC"],"package_ndc":["36800-784-96"],"product_ndc":["36800-784"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["fcc77456-2add-4ebd-be0f-e744101db96e"],"spl_set_id":["9f1c078d-e537-4ec0-8ae9-54c98282be29"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["Packaging PRINCIPAL DISPLAY PANEL - 96 Softgel Bottle Label"],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions? Call toll free: 1-888-423-0139"],"set_id":"9f1c078d-e537-4ec0-8ae9-54c98282be29","spl_product_data_elements":["Sleep Aid Nighttime Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 PROPYLENE GLYCOL WATER SORBITOL SORBITAN TITANIUM DIOXIDE 785"],"spl_unclassified_section":["Drug Facts","TopCare® health MAXIMUM STRENGTH • Fall Asleep Fast • Safe, Non-Habit Forming COMPARE TO UNISOM ® SLEEPGELS ® ACTIVE INGREDIENT* DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom ® . DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 ©TOPCO STVA0421 topcare@topco.com www.topcarebrand.com This TopCare® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed."],"storage_and_handling":["Other information store at 20°-25°C (68°-77°F)"],"version":"4","warnings":["Warnings Do not use • for 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 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."]}