{"active_ingredient":["Active ingredient (in each 5 mL) Diphenhydramine HCl USP 12.5 mg"],"ask_doctor":["Ask a doctor before use if you have ▪ glaucoma ▪ a sodium restricted diet ▪ trouble urinating due to an enlarged prostate gland ▪ a breathing problem such as emphysema or chronic bronchitis"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers."],"do_not_use":["Do not use ▪ to make a child sleepy ▪ with any other product containing diphenhydramine, including one applied topically."],"dosage_and_administration":["Directions ▪ take every 4 to 6 hours ▪ do not take more than 6 doses in 24 hours ▪ use only with enclosed dosing cup. Do not use with any other device ▪ find right dose on chart below ▪ mL = milliliter adults and children 12 years and over 10-20mL (25 mg to 50 mg) children 6 to under 12 years 5-10mL (12.5 mg to 25 mg) children 2 to 5 years of age do not use unless directed by a doctor children under 2 years of age do not use"],"dosage_and_administration_table":["
adults and children 12 years and over10-20mL (25 mg to 50 mg)
children 6 to under 12 years5-10mL (12.5 mg to 25 mg)
children 2 to 5 years of agedo not use unless directed by a doctor
children under 2 years of agedo not use
"],"effective_time":"20241101","id":"f7524b5a-015c-4966-a392-b7ab991793b0","inactive_ingredient":["Inactive ingredients artificial cherry flavor, citric acid, D&C Red #33, FD&C Red #40, glycerin, polysorbate 20, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution"],"indications_and_usage":["Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies ▪ runny nose ▪ sneezing ▪ itchy, watery eyes ▪ itching of the nose or throat"],"keep_out_of_reach_of_children":["Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label MAJOR ® NDC 0904-1228-00 TAMPER-EVIDENT Banophen™ ALLERGY Antihistamine 12.5 mg Diphenhydramine HCl USP ALCOHOL FREE FOR THE TEMPORARY RELIEF OF: Upper Respiratory Allergies Hay Fever The Common Cold Compare to the active ingredient of Benadryl ® Allergy Liquid* 4 FL. OZ. (118 mL) bottle label"],"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":"bafdad7e-20f4-4142-82cc-6d5d175554f4","spl_product_data_elements":["banophen Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CHERRY ANHYDROUS CITRIC ACID D&C RED NO. 33 FD&C RED NO. 40 GLYCERIN POLYSORBATE 20 WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL Bluish-Red"],"spl_unclassified_section":["Drug Facts","Distributed by: MAJOR ® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152"],"storage_and_handling":["Other information ▪ each (5 mL) contains: sodium 7 mg ▪ TAMPER-EVIDENT: Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing ▪ store at room temperature 20°-25°C (68°-77°F)"],"version":"6","warnings":["Warnings Do not use ▪ to make a child sleepy ▪ with any other product containing diphenhydramine, including one applied topically. Ask a doctor before use if you have ▪ glaucoma ▪ a sodium restricted diet ▪ trouble urinating due to an enlarged prostate gland ▪ a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product ▪ marked drowsiness may occur ▪ avoid alcoholic drinks ▪ 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"when_using":["When using this product ▪ marked drowsiness may occur ▪ avoid alcoholic drinks ▪ alcohol, sedatives, and tranquilizers may increase drowsiness ▪ use caution when driving a motor vehicle or operating machinery ▪ excitability may occur, especially in children"]}