{"active_ingredient":["Active i ngredient (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 ■ sedatives 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":"20260325","id":"d16a629c-c038-4ab2-a330-9df512db0288","inactive_ingredient":["Inactive I ngredients dibasic calcium 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 rea ch of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["ANDA040564"],"brand_name":["Unisom SleepTabs"],"generic_name":["DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["Chattem, Inc."],"package_ndc":["41167-0608-4","41167-0608-0","41167-0608-1","41167-0608-2","41167-0608-3"],"product_ndc":["41167-0608"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1101446","1101448"],"spl_id":["d16a629c-c038-4ab2-a330-9df512db0288"],"spl_set_id":["7ae32d74-76a0-47e2-9e5c-812426413c4e"],"substance_name":["DOXYLAMINE SUCCINATE"],"unii":["V9BI9B5YI2"]},"package_label_principal_display_panel":["Principal Display Panel Unisom Sleep T abs Doxylamine succinate tablets, 25 mg NI GHTTIME SLEEP-AID Unisom SleepTabs Doxylamine succinate tablets, 25 mg NIGHTTIME SLEEP-AID"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions or comments? 1-866-844-2798 Monday - Friday 8am-6pm ET"],"set_id":"7ae32d74-76a0-47e2-9e5c-812426413c4e","spl_product_data_elements":["Unisom SleepTabs Doxylamine Succinate DOXYLAMINE SUCCINATE DOXYLAMINE DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO Light Blue Unisom;ST"],"spl_unclassified_section":["Drug Facts","Other information ■ TAMPER EVIDENT : DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING ■ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN ■ store at controlled room temperature 20º-25ºC (68º-77ºF) ■ see end flap for expiration date and lot number ■ use by expiration date on package"],"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":"1","warnings":["Warnings S ee carton fo r complete 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 ■ sedatives 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 rea ch 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 beverages ■ do not drive a motor vehicle or operate machinery ■ take only at bedtime"]}