{"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":"20250326","id":"9e5b860c-237c-48e6-a2a0-91ab1492bae3","inactive_ingredient":["Inactive ingredients anhydrous dibasic calcium phosphate, arabic gum, artificial flavor, carmine, dibasic calcium phosphate dihydrate, FD&C blue no. 2 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, modified food starch, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, sucralose, talc, titanium dioxide, triacetin"],"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":["76162-603-67"],"product_ndc":["76162-603"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1101446"],"spl_id":["9e5b860c-237c-48e6-a2a0-91ab1492bae3"],"spl_set_id":["c8b24ed8-34a1-4857-8fcb-6e3f9d407903"],"substance_name":["DOXYLAMINE SUCCINATE"],"unii":["V9BI9B5YI2"]},"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 BERRY FLAVOR 48 TABLETS actual size 1 Tablet Dose topcare-sleep-aid-berry-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? 1-888-423-0139"],"set_id":"c8b24ed8-34a1-4857-8fcb-6e3f9d407903","spl_product_data_elements":["topcare sleep aid doxylamine succinate DOXYLAMINE SUCCINATE DOXYLAMINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE ACACIA DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 2 ALUMINUM LAKE MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A SUCRALOSE TALC TITANIUM DIOXIDE TRIACETIN 15N"],"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"]}