{"active_ingredient":["Active ingredient (in each tablet) Diphenhydramine HCl 25 mg"],"ask_doctor":["Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the 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 for children under 12 years of age with any other product containing diphenhydramine, even one used on skin"],"dosage_and_administration":["Directions do not take more than directed adults and children 12 years and over: take 2 tablets at bedtime if needed or as directed by a doctor children under 12 years: do not use"],"effective_time":"20260803","id":"514781e2-5cae-41ff-8039-b88cb5518bfc","inactive_ingredient":["Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid"],"indications_and_usage":["Use s for relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M010"],"brand_name":["Sleep Tabs"],"generic_name":["DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["Major Pharmaceuticals"],"package_ndc":["0904-4274-51"],"product_ndc":["0904-4274"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049630"],"spl_id":["514781e2-5cae-41ff-8039-b88cb5518bfc"],"spl_set_id":["ff8b7346-5be5-4e76-9ee2-d52fab66f6c5"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0309044274515"]},"package_label_principal_display_panel":["Principal Display Panel MAJOR® NDC 0904-4274-51 compare to the active ingredient in Original Formula Sominex®* sleep tabs diphenhydramine HCl 25 mg nighttime sleep-aid actual size 50 tablets Major 44-189 Major 44-189"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"set_id":"ff8b7346-5be5-4e76-9ee2-d52fab66f6c5","spl_product_data_elements":["Sleep Tabs Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE STEARIC ACID 44;189"],"spl_unclassified_section":["Questions or comments? 1-800-426-9391"],"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."],"storage_and_handling":["Other information each tablet contains: calcium 60 mg protect from moisture store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number"],"version":"21","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 glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product avoid alcoholic beverages. 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. In case of overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product avoid alcoholic beverages."]}