{"active_ingredient":["Active i ngredient (in each cap let) 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 with other antihistamines"],"dosage_and_administration":["Directions adults and children 12 years and older : take 2 tablets at bedtime if needed, or as directed by your doctor"],"effective_time":"20251023","id":"322a3f7f-6a0f-43b9-9819-9ec52e856404","inactive_ingredient":["Inactive ingredients croscarmellose sodium, dicalcium phosphate, FD&C blue no. 1 lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearate acid, talc, titanium dioxide, triacetin"],"indications_and_usage":["Use helps reduce difficultly falling asleep"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of o verdose , get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"openfda":{"application_number":["M010"],"brand_name":["Sominex"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Medtech Products Inc."],"package_ndc":["63029-554-32","63029-554-16","63029-554-01"],"product_ndc":["63029-554"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049630","1086986"],"spl_id":["322a3f7f-6a0f-43b9-9819-9ec52e856404"],"spl_set_id":["f7858ecf-8498-4465-85d8-3e7814737573"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"other_safety_information":["Other information store at room temperature 20º- 25ºC (68º-77ºF)"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL MAXIMUM STRENGTH FORMULA Sominex ® NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl 16 TABLETS MAXIMUM STRENGTH FORMULA Sominex® NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl 16 TABLETS"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions? 1-866-255-5202"],"set_id":"f7858ecf-8498-4465-85d8-3e7814737573","spl_product_data_elements":["Sominex DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE LIGHT MINERAL OIL MAGNESIUM STEARATE SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN Light Blue S;S"],"spl_unclassified_section":["Drug Facts"],"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."],"version":"3","warnings":["Warnings Do not use in children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other antihistamines 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 beverages be careful when driving a motor vehicle or operating machinery drowsiness will occur 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 o verdose , get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"when_using":["When using this product avoid alcoholic beverages be careful when driving a motor vehicle or operating machinery drowsiness will occur"]}