{"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 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 (50mg) at bedtime if needed, or as directed by a doctor"],"effective_time":"20241118","id":"272a7138-2a98-8e62-e063-6394a90a1af1","inactive_ingredient":["Inactive ingredients FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution and white edible ink"],"indications_and_usage":["Use for the relief of occasional sleeplessness"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M010"],"brand_name":["Nighttime SLEEP AID"],"generic_name":["DIPHENHYDRAMINE HCL 50MG"],"is_original_packager":[true],"manufacturer_name":["PuraCap Pharmaceutical LLC"],"package_ndc":["51013-817-01"],"product_ndc":["51013-817"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020477"],"spl_id":["272a7138-2a98-8e62-e063-6394a90a1af1"],"spl_set_id":["272a7138-2a97-8e62-e063-6394a90a1af1"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0351013817018"]},"overdosage":["In case of overdose, get medical help or contact a Poison Control Center right away."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Nighttime SLEEP-AID 100 Softgels Diphenhydramine HCl 50mg compare to active ingredient in Unisom ® SleepGels ® SoftGels NDC 51013-817-01 PC11-00 Diphen 50mg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions or comments? Call toll free: 1-855-215-8180"],"set_id":"272a7138-2a97-8e62-e063-6394a90a1af1","spl_product_data_elements":["Nighttime SLEEP AID Diphenhydramine HCl 50mg FD&C BLUE NO. 1 GLYCERIN GELATIN SORBITOL DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE WATER POLYETHYLENE GLYCOL, UNSPECIFIED PC5 clear blue"],"spl_unclassified_section":["Drug Facts"],"stop_use":["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."],"storage_and_handling":["Other information store at room temperature 15°-30° C (59°-86° F)"],"version":"1","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 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. In case of overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product avoid alcoholic drinks"]}