{"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 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 sedative or any other sleep-aid tranquilizers any other antihistamines any other drugs"],"do_not_use":["Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep"],"dosage_and_administration":["Directions adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years of age: do not use"],"effective_time":"20260114","id":"32b4f344-3f75-4804-b8cb-800fe2b508c0","inactive_ingredient":["Inactive ingredients anhydrous dibasic calcium phosphate, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate Questions or comments: 1-8 66-844-2798 Monday- Friday 8am-6pm EST"],"indications_and_usage":["Uses 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":["ANDA040167"],"brand_name":["Unisom SleepTabs"],"generic_name":["DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["Chattem, Inc."],"package_ndc":["41167-0063-5","41167-0063-6","41167-0063-7","41167-0063-8"],"product_ndc":["41167-0063"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1101446","1101448"],"spl_id":["32b4f344-3f75-4804-b8cb-800fe2b508c0"],"spl_set_id":["f591d52f-5610-4517-a96f-1ed63deb00bc"],"substance_name":["DOXYLAMINE SUCCINATE"],"unii":["V9BI9B5YI2"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Unisom Sleeptabs Doxylamine succinate 25 mg Nighttime Sleep-Aid 32 Tablets Unisom Sleeptabs Doxylamine succinate 25 mg Nighttime Sleep-Aid 32 Tablets"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"set_id":"f591d52f-5610-4517-a96f-1ed63deb00bc","spl_product_data_elements":["Unisom SleepTabs Doxylamine Succinate DOXYLAMINE SUCCINATE DOXYLAMINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 ALUMINUM OXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO Unisom;ST"],"spl_unclassified_section":["Unisom ® SleepTabs ® Doxylamine succinate tablets Nighttime Sleep-Aid Drug Facts","Other information Store at 20º to 25ºC (68 º-77 ºF) Keep carton. It contains important information"],"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."],"version":"5","warnings":["Warnings Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep 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 sedative or any other sleep-aid tranquilizers any other antihistamines any other drugs When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery 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 do not drive a motor vehicle or operate machinery take only at bedtime"]}