{"active_ingredient":["Active ingredient (in each softgel) Diphenhydramine HCl 25 mg"],"ask_doctor":["Ask a doctor before use if you have ■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma ■ difficulty in urination due to enlargement of the 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 ■ take only one dose per day (24 hours) adults & children 12 yrs & over 2 softgels at bedtime if needed or as directed by a doctor children under 12 yrs do not use"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>  adults &amp; children 12 yrs &amp; over  </td><td>2 softgels at bedtime if needed or as directed by a doctor</td></tr><tr><td>children under 12 yrs</td><td>do not use</td></tr></tbody></table>"],"effective_time":"20240417","id":"16443f3d-c881-1fe3-e063-6394a90a4e4d","inactive_ingredient":["Inactive ingredients FD&C blue no. 1, FD&C red no. 40, gelatin, polyethylene glycol 400, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide."],"indications_and_usage":["Uses ■ for the relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep"],"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":["EZ Nite Sleep"],"generic_name":["DIPHENHYRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["KROGER COMPANY"],"package_ndc":["41226-613-24"],"product_ndc":["41226-613"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049909"],"spl_id":["16443f3d-c881-1fe3-e063-6394a90a4e4d"],"spl_set_id":["0fec16a4-b4eb-8f8f-e063-6394a90a7327"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"other_safety_information":["Other information ■ store at 20-25° C (68-77°F) ■ avoid excessive heat above 40°C (104°F) ■ protect from light"],"package_label_principal_display_panel":["diphenhydramine-sg-24s-ifc"],"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 1-800-632-6900"],"set_id":"0fec16a4-b4eb-8f8f-e063-6394a90a7327","spl_product_data_elements":["EZ Nite Sleep Diphenhyramine Hydrochloride PROPYLENE GLYCOL POLYETHYLENE GLYCOL 400 SHELLAC WATER TITANIUM DIOXIDE FD&C RED NO. 40 GELATIN SORBITOL SOLUTION FD&C BLUE NO. 1 SORBITAN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 121 oblong shaped Purple,translucent"],"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."],"version":"2","warnings":["Warnings Do not use ■ for children under 12 years of age ■ with any other product containing diphenhydramine, even one used on skin. 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 ■ difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product ■ avoid alcoholic beverages 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 (1-800-222-1222) right away."],"when_using":["When using this product ■ avoid alcoholic beverages"]}