{"active_ingredient":["Active ingredient (in each caplet) Diphenhydramine HCl 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 sedatives or tranquilizers"],"do_not_use":["Do not use in children under 12 years of age with any other product containing diphenhydramine, even one used on skin"],"dosage_and_administration":["Directions adults and children 12 years and over take 2 caplets at bedtime if needed, or as directed by a doctor children under 12 years do not use"],"dosage_and_administration_table":["<table width=\"55%\" styleCode=\"Noautorules\"><col width=\"30%\" align=\"left\" valign=\"top\"/><col width=\"70%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Rrule Toprule\">adults and children 12 years and over</td><td styleCode=\"Toprule\">take 2 caplets at bedtime if needed, or as directed by a doctor</td></tr><tr><td styleCode=\"Rrule\">children under 12 years</td><td>do not use</td></tr></tbody></table>"],"effective_time":"20250602","id":"369b679c-4911-8ef8-e063-6394a90abd0a","inactive_ingredient":["Inactive ingredients carnauba wax, croscarmellose sodium, dibasic calcium phosphate, FD&C Blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide"],"indications_and_usage":["Use for relief of occasional sleeplessness"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M010"],"brand_name":["Simply Sleep"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Kenvue Brands LLC"],"package_ndc":["50580-843-11","50580-843-12"],"product_ndc":["50580-843"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049630","1092466"],"spl_id":["369b679c-4911-8ef8-e063-6394a90abd0a"],"spl_set_id":["37c606b0-04d5-49f0-886a-3ee2c9b0e9cc"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0300450843104"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL FROM THE MAKERS OF TYLENOL ® PM NDC 50580-843-12 Non-habit Forming Simply Sleep ® Diphenhydramine HCl Nighttime Sleep Aid Does NOT Contain Pain Reliever *Capsule-Shaped Tablets Actual Size 100 Caplets* PRINCIPAL DISPLAY PANEL"],"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 1-877-895-3665 (toll-free) or 215-273-8755 (collect)"],"set_id":"37c606b0-04d5-49f0-886a-3ee2c9b0e9cc","spl_product_data_elements":["Simply Sleep diphenhydramine hydrochloride MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CARNAUBA WAX CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 ALUMINUM LAKE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE Light blue SL"],"spl_unclassified_section":["Drug Facts"],"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 each caplet contains: calcium 15 mg store between 20-25°C (68-77°F). Avoid high humidity. Protect from light. do not use if carton tape or foil inner seal imprinted with \"SAFETY SEAL®\" is broken or missing"],"version":"11","warnings":["Warnings Do not use in 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 drowsiness will occur do not drive a motor vehicle or operate machinery 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. 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. (1-800-222-1222)"],"when_using":["When using this product avoid alcoholic drinks drowsiness will occur do not drive a motor vehicle or operate machinery"]}