{"active_ingredient":["Active Ingredient (in each tablet) 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 A dults and children 12 years and older : take 2 tablets at bedtime if needed, or as directed by your doctor"],"effective_time":"20241003","id":"2396151b-13a0-cc41-e063-6394a90aa45b","inactive_ingredient":["Inactive ingredients cellulose, microcrystalline, croscarmellose sodium, FD&C blue no. 1, hypromellose, lactose monohydrate, light mineral oil, magnesium stearate, silicon dioxide, stearic 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 accidental overdose get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M010"],"brand_name":["Sominex"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"manufacturer_name":["Navajo Manufacturing Company Inc."],"original_packager_product_ndc":["63029-554"],"package_ndc":["67751-221-01"],"product_ndc":["67751-221"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049630","1086986"],"spl_id":["2396151b-13a0-cc41-e063-6394a90aa45b"],"spl_set_id":["f70ce1a6-c334-025e-e053-6294a90ae53f"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Sominex"],"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 weekdays or visit www.sominex.com"],"set_id":"f70ce1a6-c334-025e-e053-6294a90ae53f","spl_product_data_elements":["Sominex DIPHENHYDRAMINE HYDROCHLORIDE 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 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE Light Blue S;S"],"spl_unclassified_section":["Drug Facts","Other information each tablet contains: calcium 12 mg store at 20º- 25ºC (68º-77ºF)"],"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":"2","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 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 accidental overdose get medical help or contact a Poison Control Center right away."],"when_using":["When using this product avoid alcoholic beverages be careful when driving a motor vehicle or operating machinery"]}