{"active_ingredient":["Active ingredient (in each liquid-filled capsule) Diphenhydramine HCl 50 mg"],"ask_doctor":["Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis 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 adults and children 12 years and over: 1 capsule (50 mg) at bedtime if needed, or as directed by a doctor"],"effective_time":"20191119","id":"1cf67233-2fe5-4f2f-9c1d-650d41da2085","inactive_ingredient":["Inactive ingredients edible white ink, FD&C blue #1, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, purified water, sorbitol"],"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 (1-800-222-1222) right away."],"openfda":{},"package_label_principal_display_panel":["Principal display panel ASSURED™ COMPARE TO ACTIVE INGREDIENT OF UNISOM ® SLEEPGELS®* MAXIMUM STRENGTH Sleep Aid • Diphenhydramine HCI 50 mg Nighttime Sleep-Aid Helps reduce difficulty falling asleep Fast acting, Non-habit forming Actual Size 8 softgels TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING ITEM # 934526 DISTRIBUTED BY GREENBRIER INTERNATIONAL, INC. 500 VOLVO PARKWAY, CHESAPEAKE, VA 23320 *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®. 50844 REV0315A65619 Product of China Packaged and Quality Assured in the USA Assured 44-656 Assured 44-656"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions or comments? 1-800-426-9391"],"set_id":"ddde8663-331e-4d28-9447-3c62601bc2e1","spl_product_data_elements":["Sleep Aid Maximum Strength Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN MINERAL OIL POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITOL LECITHIN, SOYBEAN clear 656"],"stop_use":["Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness."],"storage_and_handling":["Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) avoid excessive heat see end flap for expiration date and lot number"],"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 glaucoma a breathing problem such as emphysema or chronic bronchitis 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 a 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."]}