{"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":"20191113","id":"e8b68c89-b31e-4be8-a024-f1e7549df522","inactive_ingredient":["Inactive ingredients FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink"],"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 - Bottle Label TopCare Nighttime Sleep Aid Diphenhydramine HCl 50 mg 96SOFTGELS NDC 36800-413-96 *Compare to the active ingredient in Unisom ® SleepGels ® Bottle Label Front Bottle Label Back"],"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: 1-888-423-0139"],"set_id":"8f6e0e6b-cd6f-4600-8075-e3a3d503c419","spl_product_data_elements":["Nighttime Sleep Aid Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITOL clear oval PC5"],"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 15°-30°C (59°-86°F)"],"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 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"]}