{"active_ingredient":["Active ingredient (in each softgel) Diphenhydramine HCl 50 mg"],"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 doctor or pharmacist before use if you are taking sedatives or tranquilizers"],"do_not_use":["Do not use • for children under 12 years of age • with any other product containing diphenhydramine, even one used on skin"],"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":"20251205","id":"453c8cfa-4363-8b3c-e063-6294a90a5563","inactive_ingredient":["Inactive ingredients FD&C Blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide"],"indications_and_usage":["Uses • for relief of occasional sleeplessness"],"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 (1-800-222-1222) right away."],"openfda":{"application_number":["M010"],"brand_name":["Nighttime Sleep Aid"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Shield Pharmaceuticals Corp"],"package_ndc":["83059-0122-6"],"product_ndc":["83059-0122"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020477"],"spl_id":["453c8cfa-4363-8b3c-e063-6294a90a5563"],"spl_set_id":["97eb3e4d-06b7-49ed-909b-95b523dcce41"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0611419406378"]},"other_safety_information":["Other information • store at controlled room temperature 20-25ºC (68-77ºF) • protect from light, heat and moisture"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Compare to the active ingredient in Unisom® SleepGels Sleep-Aid Diphenhydramine HCI Softgels, 50 mg Label Label-Front Label-Back"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions or comments? 1-800-373-6981"],"set_id":"97eb3e4d-06b7-49ed-909b-95b523dcce41","spl_product_data_elements":["Nighttime Sleep Aid Diphenhydramine Hydrochloride FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SORBITOL SORBITAN TITANIUM DIOXIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE SDU"],"spl_unclassified_section":["Drug Facts","Distributed by: Shield Pharmaceuticals Corp. Ronkonkoma, NY 11779"],"stop_use":["Stop use and ask a doctor if sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness."],"version":"2","warnings":["Warnings"],"when_using":["When using this product avoid alcoholic drinks"]}