{"active_ingredient":["Active ingredient (in each tablet) Doxylamine succinate 25 mg"],"ask_doctor":["Ask a doctor before use if you have a breathing problem such as asthma, emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking any other drugs."],"dosage_and_administration":["Directions adults and children 12 years and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years: do not use"],"effective_time":"20250226","id":"2f0e58dc-121b-d508-e063-6294a90a34ff","inactive_ingredient":["Inactive ingredients dicalcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate"],"indications_and_usage":["Use helps to reduce difficulty in falling asleep"],"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. [1-800-222-1222]"],"openfda":{"application_number":["ANDA040564"],"brand_name":["Night Time Sleep Aid"],"generic_name":["DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["Advanced Rx LLC"],"package_ndc":["80513-371-25"],"product_ndc":["80513-371"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1101446"],"spl_id":["2f0e58dc-121b-d508-e063-6294a90a34ff"],"spl_set_id":["db8b730a-1553-4682-96bf-41e670ed0347"],"substance_name":["DOXYLAMINE SUCCINATE"],"unii":["V9BI9B5YI2"],"upc":["0380513000897"]},"package_label_principal_display_panel":["*Compare to the active ingredient in Unisom ® Sleeptabs ® NDC 80513-371-25 Night Time Sleep Aid Doxylamine Succinate 25 mg 225 Tablets *This product is not manufactured or distributed by the owner of the registered trademark Unisom ® Sleeptabs ® . Good Neighbor 44-386 Good Neighbor 44-386 label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions? call toll-free 1-800-630-8895"],"set_id":"db8b730a-1553-4682-96bf-41e670ed0347","spl_product_data_elements":["Night Time Sleep Aid Doxylamine Succinate DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A DOXYLAMINE SUCCINATE DOXYLAMINE light blue 44;386"],"spl_unclassified_section":["Distributed by: ADVANCED RX LLC 1942 NE 163rd St North Miami Beach, FL 33162 U.S.A"],"stop_use":["Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness."],"storage_and_handling":["Other information store at 20°-25°C (68° and 77° F) protect from excessive moisture DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED."],"version":"2","warnings":["Warnings Ask a doctor before use if you have a breathing problem such as asthma, emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking any other drugs. When using this product avoid alcoholic beverages take only at bedtime Stop use and ask a doctor if sleeplessness persists continuously for more than two 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. [1-800-222-1222]"],"when_using":["When using this product avoid alcoholic beverages take only at bedtime"]}