{"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 • 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 • with any other product containing diphenhydramine, even one used on skin"],"dosage_and_administration":["Directions • do not take more than directed • take every 4 to 6 hours, or as directed by a doctor • do not take more than 6 times in 24 hours adults and children 12 years and over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use"],"dosage_and_administration_table":["
adults and children 12 years and over1 to 2 tablets
children 6 to under 12 years1 tablet
children under 6 years do not use
"],"effective_time":"20231201","id":"449c7ca6-7fd4-4728-b330-2a3e261c6693","inactive_ingredient":["Inactive ingredients corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide"],"indications_and_usage":["Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: o runny nose o itchy, watery eyes o sneezing o itching of the nose or throat • temporarily relieves these symptoms due to the common cold: o runny nose o sneezing"],"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":["M012"],"brand_name":["Banophen"],"generic_name":["DIPHENHYDRAMINE HCL"],"manufacturer_name":["Proficient Rx LP"],"original_packager_product_ndc":["0904-5551"],"package_ndc":["71205-611-20","71205-611-30","71205-611-60","71205-611-90"],"product_ndc":["71205-611"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049630","1092421"],"spl_id":["449c7ca6-7fd4-4728-b330-2a3e261c6693"],"spl_set_id":["62934d0f-b23d-4c03-9d60-a7bad41f9b42"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0371205611200"]},"package_label_principal_display_panel":["Principal Display Panel NDC 71205-611-20 Compare to the active ingredient in Benadryl ® Allergy ULTRATAB ® Tablets* Banophen Diphenhydramine HCl 25 mg Antihistamine / Allergy Relief Relieves Sneezing, Runny Nose, Itchy Throat and Itchy, Watery Eyes Actual Size 20 Minitabs *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy ULTRATAB® Tablets. 50844 REV1220M32908 Rev. 03/21 M-17 Re-order No. 250050 Distributed by: MAJOR ® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA Repackaged by: PROFICIENT RX LP Thousand Oaks, CA 91320 TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 71205-611-20"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? (800)-616-2471"],"set_id":"62934d0f-b23d-4c03-9d60-a7bad41f9b42","spl_product_data_elements":["Banophen Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE MICROCRYSTALLINE CELLULOSE D&C RED NO. 27 ALUMINUM LAKE DIBASIC CALCIUM PHOSPHATE DIHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE STARCH, CORN POLYVINYL ALCOHOL, UNSPECIFIED TALC 44;329"],"storage_and_handling":["Other information • each tablet contains: calcium 30 mg • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) • protect from moisture • see end flap for expiration date and lot number"],"version":"3","warnings":["Warnings Do not use • 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 • 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 • marked drowsiness may occur • avoid alcoholic beverages • alcohol, sedatives, and tranquilizers may increase drowsiness • use caution when driving a motor vehicle or operating machinery • excitability may occur, especially in children 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 • marked drowsiness may occur • avoid alcoholic beverages • alcohol, sedatives, and tranquilizers may increase drowsiness • use caution when driving a motor vehicle or operating machinery • excitability may occur, especially in children"]}