{"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 • a 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":"20250331","id":"6aed4ba1-211a-4e76-bc4c-0ca3a57fb66a","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"],"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":["ANDA040167"],"brand_name":["berkley and jensen sleep aid"],"generic_name":["DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["BJWC"],"package_ndc":["68391-441-02"],"product_ndc":["68391-441"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1101446"],"spl_id":["6aed4ba1-211a-4e76-bc4c-0ca3a57fb66a"],"spl_set_id":["25f468a9-71d4-40f2-97bb-1c3ff5d4b728"],"substance_name":["DOXYLAMINE SUCCINATE"],"unii":["V9BI9B5YI2"]},"package_label_principal_display_panel":["Principal Display Panel Compare to the active ingredient in Unisom ® SleepTabs ® berkley jensen ® SLEEP AID DOXYLAMINE SUCCINATE TABLETS, 25 mg NIGHTTIME SLEEP-AID ACTUAL SIZE 192 TABLETS ONE TABLET PER DOSE 2-96 COUNT BOTTLES berkley-jensen-sleep-aid-carton-image.jpg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"25f468a9-71d4-40f2-97bb-1c3ff5d4b728","spl_product_data_elements":["berkley and jensen sleep aid Doxylamine succinate DOXYLAMINE SUCCINATE DOXYLAMINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A L441"],"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 (68-77°F) • keep carton. It contains important information."],"version":"3","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 • a 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"]}