{"active_ingredient":["Active ingredient (in each tablet )"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you ●have ▪a breathing problem such as emphysema or chronic bronchitis ▪glaucoma ▪difficulty urinating ●take sedatives or tranquilizers ●are pregnant or breastfeeding"],"do_not_use":["Do not use ●if you are elderly, as this drug may cause excitation rather than sedation ●with any other product containing diphenhydramine, even one used on skin ●in children under 12 years of age"],"dosage_and_administration":["Directions Adults and children 12 years and over: ▪ take 1 tablet at bedtime if needed, or as directed by a doctor ▪ if you feel drowsy in the morning, consult a doctor or pharmacist as you may require a lower dosage (25 mg) ▪ do not take more than directed"],"effective_time":"20240118","id":"4f4da6bc-aaff-4dca-8125-ce43c053f9bc","inactive_ingredient":["Inactive ingredients anhydrous dibasic calcium phosphate, croscarmellose sodium, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, mineral oil, silicon dioxide, stearic acid, talc, titanium dioxide, triacetin, water SECURITY FEATURE: Safety sealed in individual pouches. Do not use if pouch is not safely sealed. Important: Keep carton for future reference."],"indications_and_usage":["Uses ● relieves occasional sleeplessness ● helps to reduce difficulty falling asleep"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, call a poison control centre or get medical help right away."],"openfda":{},"other_safety_information":["Other information ▪ Store at 20° to 25°C"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Sleep.eze Extra strength Caplets 10 coated capsules PRINCIPAL DISPLAY PANEL Sleep.eze Extra strength Caplets 10 coated capsules"],"purpose":["Purpose Diphenhydramine Hydrochloride 50 mg………………..Nighttime sleep aid"],"set_id":"31d3dcb1-0898-4fee-b236-2f1096b0d787","spl_product_data_elements":["Sleepeze DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 ALUMINUM LAKE HYPROMELLOSES LACTOSE MONOHYDRATE MINERAL OIL MAGNESIUM STEARATE SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN WATER S;Z"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if sleeplessness continues for more than 2 weeks. Sleeplessness may be a symptom of a serious underlying medical illness."],"version":"2","warnings":["Warnings Do not use ●if you are elderly, as this drug may cause excitation rather than sedation ●with any other product containing diphenhydramine, even one used on skin ●in children under 12 years of age Ask a doctor or pharmacist before use if you ●have ▪a breathing problem such as emphysema or chronic bronchitis ▪glaucoma ▪difficulty urinating ●take sedatives or tranquilizers ●are pregnant or breastfeeding When using this product avoid drinking alcohol. Stop use and ask a doctor if sleeplessness continues for more than 2 weeks. Sleeplessness may be a symptom of a serious underlying medical illness. Keep out of reach of children. In case of overdose, call a poison control centre or get medical help right away."],"when_using":["When using this product avoid drinking alcohol."]}