{"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":"20240328","id":"d7fff893-f18b-4114-91fe-e9c1b1e3bbc6","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":["Topcare Sleep Aid"],"generic_name":["DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["Topco Associates LLC"],"package_ndc":["76162-159-62","76162-159-67"],"product_ndc":["76162-159"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1101446"],"spl_id":["d7fff893-f18b-4114-91fe-e9c1b1e3bbc6"],"spl_set_id":["d0295e0b-aba8-4cc7-b83c-b494d552413b"],"substance_name":["DOXYLAMINE SUCCINATE"],"unii":["V9BI9B5YI2"],"upc":["0036800498198"]},"other_safety_information":["Other information • store at 20-25 ◦ C (68-77 ◦ F) • keep carton. It contains important information."],"package_label_principal_display_panel":["Package/Label Principal Display Panel TopCare ® health COMPARE TO VICKS® ZZZQUIL® ULTRA ACTIVE INGREDIENT NIGHTTIME Sleep Aid ULTRA DOXYLAMINE SUCCINATE TABLETS, 25 mg NIGHTTIME SLEEP-AID Clinically Tested, Proven Effective 24 TABLETS actual size 1 Tablet Dose Sleep Aid Carton Image 1 Sleep Aid Carton Image 2"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions or comments? 1-888-423-0139"],"set_id":"d0295e0b-aba8-4cc7-b83c-b494d552413b","spl_product_data_elements":["Topcare 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."],"version":"2","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"]}