{"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 asthma, emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland heart disease"],"ask_doctor_or_pharmacist":["ask your doctor or pharmacist before use if you are taking sedative or tranquilizers or any other sleep-aid"],"do_not_use":["do not use: for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products"],"dosage_and_administration":["Directions do not take more than directed (see overdose warning) 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"],"effective_time":"20260707","id":"55fecf57-0d0f-617b-e063-6394a90a17de","inactive_ingredient":["Inactive Ingredients Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Polyvinyl Alcohol, Talc, Titanium dioxide, Polyethylene Glycol, Lecithin, Brilliant Blue (FD&C Blue No. 1), Indico Carmel (FD&C Blue No. 2), Purified Water."],"indications_and_usage":["Uses: relief of occasional sleeplessness"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms"],"openfda":{"application_number":["M010"],"brand_name":["Nighttime Sleep Aid"],"generic_name":["DIPHENHYDRAMINE HCL 25 MG"],"is_original_packager":[true],"manufacturer_name":["Health Pharma USA LLC"],"package_ndc":["71679-110-03","71679-110-06","71679-110-10"],"product_ndc":["71679-110"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049630"],"spl_id":["55fecf57-0d0f-617b-e063-6394a90a17de"],"spl_set_id":["d659f747-9790-8bd6-e053-2995a90ae793"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0371679110100","0371679110032"]},"other_safety_information":["Other Information Each caplet contains: Calcium 23.52 mg store at controlled room temperature 25°C (77°F); excursions permitted between 15-30°C (59-86°F) read all product information before using"],"package_label_principal_display_panel":["Principal Display Panel-300 count label","Principal Display Panel-600 count label","Principal Display Panel-1000 count label"],"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 toll free 1-844-832-1138 9AM – 5PM Monday - Friday"],"set_id":"d659f747-9790-8bd6-e053-2995a90ae793","spl_product_data_elements":["Nighttime Sleep Aid Diphenhydramine HCl 25 mg ANHYDROUS DIBASIC CALCIUM PHOSPHATE MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM WATER SILICON DIOXIDE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED FD&C BLUE NO. 1 FD&C BLUE NO. 2 TITANIUM DIOXIDE TALC LECITHIN, SOYBEAN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE S25"],"stop_use":["Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness."],"version":"12","warnings":["Warnings do not use: for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products ask a doctor before use if you have a breathing problem such as asthma, emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland heart disease ask your doctor or pharmacist before use if you are taking sedative or tranquilizers or any other sleep-aid When using this product drowsiness will occur avoid alcoholic beverages and other drugs that cause drowsiness excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms"],"when_using":["When using this product drowsiness will occur avoid alcoholic beverages and other drugs that cause drowsiness excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery"]}