{"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=\"100%\"><col width=\"44%\"/><col width=\"50%\"/><tbody><tr><td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><paragraph>adults and children 12 years and over</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>take 2 caplets at bedtime if needed, or as directed by a doctor</paragraph></td></tr><tr><td styleCode=\"Botrule Lrule \" valign=\"top\"><paragraph>children under 12 years </paragraph></td><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>do not use</paragraph></td></tr></tbody></table>"],"effective_time":"20240717","id":"b0cba6ea-b6ae-42a0-aaae-055d03fb8254","inactive_ingredient":["Inactive ingredients carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, 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 (1-800-222-2222)."],"openfda":{"application_number":["M010"],"brand_name":["topcare sleep aid nighttime"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Topco Associates LLC"],"package_ndc":["36800-431-62","36800-431-67","36800-431-78"],"product_ndc":["36800-431"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049630"],"spl_id":["b0cba6ea-b6ae-42a0-aaae-055d03fb8254"],"spl_set_id":["30284271-0411-4abf-bc62-d956dc794432"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["Principal Display Panel TopCare ® health COMPARE TO SIMPLY SLEEP ® ACTIVE INGREDIENT NIGHTTIME Sleep Aid DIPHENHYDRAMINE HCl 25 mg NIGHTTIME SLEEP AID • Helps You Fall Asleep • Non Habit-Forming Does Not Contain Pain Reliever 24 CAPLETS actual size sleep aid-image"],"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":"30284271-0411-4abf-bc62-d956dc794432","spl_product_data_elements":["topcare sleep aid nighttime Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CARNAUBA WAX CROSPOVIDONE (120 .MU.M) DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 FD&C BLUE NO. 2 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 STEARIC ACID TITANIUM DIOXIDE Light Blue L431"],"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 at 20-25 ° C (68-77 ° F). Avoid high humidity. Protect from light. • do not use if blister unit is broken or torn"],"version":"8","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 may 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 (1-800-222-2222)."],"when_using":["When using this product • avoid alcoholic drinks • drowsiness may occur • do not drive a motor vehicle or operate machinery"]}