{"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":"20241217","id":"297e337b-1ce0-a590-e063-6394a90aad40","inactive_ingredient":["Inactive ingredients FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol solution, titanium dioxide"],"indications_and_usage":["Use 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 right away."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL image description"],"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: 1-888-333-9792"],"set_id":"911b3bf5-500a-4c22-b21d-5ef52a05bbbc","spl_product_data_elements":["MAXIMUM STRENGTH Nighttime Sleep Aid Diphenhydramine Hydrochloride FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 WATER SORBITOL TITANIUM DIOXIDE PROPYLENE GLYCOL DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE Blue to greenish blue 206;903"],"spl_unclassified_section":["Drug Facts"],"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."],"storage_and_handling":["Other information Store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat do not use if imprinted safety seal under cap is broken or missing"],"version":"6","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 an 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 persist 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"]}