{"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 or 2 tablets at bedtime if needed, or as directed by a doctor ▪if you feel drowsy in the morning, reduce dose to 1 tablet ▪do not take more than directed"],"effective_time":"20240112","id":"d3a12906-d2fa-4ce3-9123-4eae4a435748","inactive_ingredient":["Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearic acid, talc, titanium dioxide, triacetin"],"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 Regular Strength Caplets Diphenhydramine Hydrochloride Tablets 25 mg 20 coated caplets PRINCIPAL DISPLAY PANEL Sleep.eze Regular Strength Caplets Diphenhydramine Hydrochloride Tablets 25 mg 20 coated caplets"],"purpose":["Purpose Diphenhydramine Hydrochloride 25 mg………………Nighttime sleep aid"],"questions":["Questions? 1-800-443-4908"],"set_id":"e4794600-9b15-4dad-a605-d6c2841ff375","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 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."]}