{"active_ingredient":["Active ingredient (in each softgel) Diphenhydramine HCl 50 mg"],"dosage_and_administration":["Directions • adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor"],"effective_time":"20250801","id":"267da9a1-6c85-4316-9aad-3fe5762c347a","inactive_ingredient":["Inactive ingredients FD&C blue No. 1, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide"],"indications_and_usage":["Use • for relief of occasional sleeplessness"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M010"],"brand_name":["TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Topco Associates LLC"],"package_ndc":["76162-438-96"],"product_ndc":["76162-438"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020477"],"spl_id":["267da9a1-6c85-4316-9aad-3fe5762c347a"],"spl_set_id":["2ea0b2cf-f055-11f6-e063-6394a90a5364"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["Packaging NIGHTTIME MAXIMUM STRENGTH"],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions? Call toll-free: 1-888-423-0139"],"set_id":"2ea0b2cf-f055-11f6-e063-6394a90a5364","spl_product_data_elements":["TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid Diphenhydramine hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SORBITOL SORBITAN TITANIUM DIOXIDE 903"],"spl_unclassified_section":["Drug Facts","®COMPARE TO UNISOM ® ​SLEEPGELS ® ​ACTIVE INGREDIENT* • Fall Asleep Fast TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143 ©TOPCO STVA0425 topcare@topco.com www.topcarebrand.com PRODUCT OF INDIA *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom ® ​. QUALITY GUARANTEED This TopCare ® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed."],"storage_and_handling":["Other information • store at controlled room temperature 20–25°C (68–77°F)"],"version":"2","warnings":["Warnings Do not use • for children under 12 years of age • with any other product containing diphenhydramine, even one used on skin 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 tranquilizers When using this product avoid alcoholic drinks Stop use and ask a doctor if sleeplessness persist continuously for more than 2 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away."]}