{"active_ingredient":["Active ingredient (in each caplet) Diphenhydramine HCl 25 mg"],"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":["
adults and children 12 years of age and overtake 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years of agedo not use
"],"effective_time":"20241211","id":"58ec0811-167c-4f70-8d72-4b9900d96f3b","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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M010"],"brand_name":["Nighttime Sleep Aid"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Strive Pharmaceuticals Inc."],"package_ndc":["70692-151-46"],"product_ndc":["70692-151"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049630"],"spl_id":["58ec0811-167c-4f70-8d72-4b9900d96f3b"],"spl_set_id":["f99cc210-b946-42a2-9164-8aa5308c5418"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["Packaging Strive-151"],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions or comments? 1-888-577-8033 Monday - Friday 8am - 4pm EST"],"set_id":"f99cc210-b946-42a2-9164-8aa5308c5418","spl_product_data_elements":["Nighttime Sleep Aid 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 DB"],"spl_unclassified_section":["Drug Facts","RIGHT REMEDIES Compare to the active ingredient of TYLENOL ® Simply Sleep ® * helps you fall asleep safe, non-habit forming TAMPER EVIDENT DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816 Product of India Packaged and Quality Assured in the USA READ AND KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Tylenol ® Simply Sleep ® . REV.00-032022"],"storage_and_handling":["Other information • each caplet contains: calcium 19 mg • store at room temperature between 20°-25°C (68°-77°F) • avoid excessive heat, light and moisture."],"version":"2","warnings":["Warnings Do not use • for 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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."]}