{"active_ingredient":["Active ingredient (in each caplet) Diphenhydramine HCl 25 mg"],"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=\"50%\"><tbody><tr><td styleCode=\"Botrule Rrule\"> adults and children 12 years and over</td><td styleCode=\"Botrule\"> 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":"20240129","id":"c548ef0a-5d1f-4b35-b29a-12abf4663212","inactive_ingredient":["Inactive ingredients croscarmellose sodium, dicalcium phosphate, FD&C blue #1, FD&C blue #2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, 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":["Kroger Nighttime Sleep Aid CAPLET"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["The Kroger Co."],"package_ndc":["59450-601-01"],"product_ndc":["59450-601"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049630"],"spl_id":["c548ef0a-5d1f-4b35-b29a-12abf4663212"],"spl_set_id":["f0f3f58d-9457-4697-98e6-ef52d350cf67"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["Packaging KROGER-601"],"purpose":["Purpose Nighttime sleep aid"],"questions":["Questions or comments? call 1- 800-632-6900"],"set_id":"f0f3f58d-9457-4697-98e6-ef52d350cf67","spl_product_data_elements":["Kroger Nighttime Sleep Aid CAPLET Diphenhydramine hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C BLUE NO. 1 FD&C BLUE NO. 2 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SILICON DIOXIDE TALC TITANIUM DIOXIDE Oblong DB"],"spl_unclassified_section":["Drug Facts","Compare to the active ingredient of TYLENOL ® PM Simply Sleep ®* Does Not Contain Pain Reliever READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 FOR MORE PRODUCT INFORMATION, SCAN UPC USING YOUR KROGER APP OR CALL 800-632-6900 Product of India *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc. McNeil Consumer Healthcare Division., owner of the registered trademark Tylenol ® PM Simply Sleep ® ."],"storage_and_handling":["Other information • each caplet contains: calcium 19 mg • store at room temperature between 20°-25°C (68°-77°F). Avoid high humidity. Protect from light."],"version":"1","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."]}