{"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 trouble urinating due to an enlarged prostate gland glaucoma"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers"],"do_not_use":["Do not use with any other product containing diphenhydramine, even one used on skin in children under 12 years of age"],"dosage_and_administration":["Directions adults and children 12 years of age and over take 2 caplets at bedtime if needed, or as directed by a doctor children under 12 years of age do not use"],"dosage_and_administration_table":["<table width=\"50%\"><col width=\"40%\" align=\"left\" valign=\"top\"/><col width=\"60%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">adults and children 12 years of age and over</td><td>take 2 caplets at bedtime if needed, or as directed by a doctor</td></tr><tr><td styleCode=\"Rrule\">children under 12 years of age</td><td>do not use</td></tr></tbody></table>"],"effective_time":"20241202","id":"284d2782-2253-c0b9-e063-6394a90aaeb3","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C blue #1, 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. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M010"],"brand_name":["Diphenhydramine Hydrochloride"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["AAA Pharmaceutical, Inc."],"package_ndc":["57344-091-03"],"product_ndc":["57344-091"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049630"],"spl_id":["284d2782-2253-c0b9-e063-6394a90aaeb3"],"spl_set_id":["c280cf02-ebb2-4847-a66d-d02aff3ea0c9"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0099581911737"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 24 Caplet Carton RESTORE U NDC 57344-091-03 † COMPARE TO THE ACTIVE INGREDIENT IN SIMPLY SLEEP ® Rest Simply actual size Diphehydramine HCl Nighttime Sleep-Aid Helps You Fall Asleep Fast, Non-Habit Forming, Use as Directed 100 CAPLETS - 25 MG EACH image description"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"set_id":"c280cf02-ebb2-4847-a66d-d02aff3ea0c9","spl_product_data_elements":["Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE SILICON DIOXIDE CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C BLUE NO. 1 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25;052"],"spl_unclassified_section":["Drug Facts","Distributed by: AAA Pharmaceutical, Inc. 681 Main Street Lumberton, NJ 08048"],"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 45 mg store at room temperature 15°-30°C (59°-86°F) retain carton for complete product information"],"version":"4","warnings":["Warnings Do not use with any other product containing diphenhydramine, even one used on skin in children under 12 years of age Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma 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 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. In case of overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product avoid alcoholic drinks"]}