{"active_ingredient":["Active Ingredient (In Each Softgel) Diphenhydramine HCl 50 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 tranquilizers."],"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":"20251229","id":"9a01f49e-a58c-4f33-8be5-2106487f6cb6","inactive_ingredient":["Inactive Ingredients: Polyethylene Glycol, Gelatin, Sorbitol, Sorbitan Anhydrous, Glycerin, Brilliant Blue FCF."],"indications_and_usage":["Uses for relief of occasional sleeplessness"],"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":["M010"],"brand_name":["SleepAid Softgels"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["PIONEER LIFE SCIENCES, LLC"],"package_ndc":["72090-023-01"],"product_ndc":["72090-023"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020477"],"spl_id":["9a01f49e-a58c-4f33-8be5-2106487f6cb6"],"spl_set_id":["9d6b5ec1-3aa4-4a19-936e-c44b04b2f3fa"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["NDC 72090-023-01 (180 Sofgels t in HDPE Bottle) PL0144 - SleepAid -180cts - Elysium 08.09.2023_page-0001"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions Or Comments? Call toll-free 1 (732) 689-5070 Monday through Friday 9 am to 5 pm EST."],"set_id":"9d6b5ec1-3aa4-4a19-936e-c44b04b2f3fa","spl_product_data_elements":["SleepAid Softgels Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE POLYETHYLENE GLYCOL, UNSPECIFIED GELATIN SORBITOL SORBITAN GLYCERIN FD&C BLUE NO. 1 cp71"],"spl_unclassified_section":["*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels® Distributed by: Gencare Consumer Products, LLC 40E Cotters Ln, Suite A, East Brunswick, NJ 08816"],"stop_use":["Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness."],"storage_and_handling":["Other Information: store between 15-30°C (59-86°F). Avoid high humidity. Protect from light."],"version":"2","warnings":["Do not use: for children under 12 years of age with any other product containing diphenhydramine, even one used on skin."]}