{"active_ingredient":["Active Ingredient (in each banded capsule) Diphenhydramine Hydrochloride 50 mg"],"ask_doctor":["Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis 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 to make a child sleepy with any other product containing diphenhydramine, even one used on skin"],"dosage_and_administration":["Directions Take every 4-6 hours Do not take more than 6 doses in 24 hours adults and children 12 years of age and over Take 1 capsule (50 mg) children under 12 years of age ask a doctor, the proper dosage strength is not available in this package** **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package."],"dosage_and_administration_table":["
adults and children 12 years of age and overTake 1 capsule (50 mg)
children under 12 years of age ask a doctor, the proper dosage strength is not available in this package**
**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.
"],"effective_time":"20260220","id":"4b4333df-2739-654b-e063-6394a90a4a1d","inactive_ingredient":["Inactive Ingredients D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch."],"indications_and_usage":["Use Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies runny nose sneezing itchy, watery eyes itchy throat and nose Temporarily relieves these symptoms due to the common cold runny nose 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"],"is_original_packager":[true],"manufacturer_name":["Major Pharmaceuticals"],"package_ndc":["0904-5307-60","0904-5307-80"],"product_ndc":["0904-5307"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020477","1020479"],"spl_id":["4b4333df-2739-654b-e063-6394a90a4a1d"],"spl_set_id":["7f2b72cc-d4f7-431f-be61-c103cf8c489e"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Major NDC 0904-5307-80 BENOPHEN Complete Allergy Medication Diphenhydramine HCl 50 mg ANTIHISTAMINE For the temporary relief from symptoms of: • Upper Respiratory Allergies • Hay Fever 1000 CAPSULES Each Capsule Individually Banded For Your Protection THIS LARGE PACKAGE SIZE FOR DISPENSING PURPOSE ONLY Major Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions? Questions or comments?1-800-231-4670"],"set_id":"7f2b72cc-d4f7-431f-be61-c103cf8c489e","spl_product_data_elements":["Banophen diphenhydramine hcl D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN LACTOSE MONOHYDRATE ANHYDROUS LACTOSE STARCH, CORN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CPC;836"],"spl_unclassified_section":["Other Information Store in a dry place at 15° – 30°C (59° – 86°F). Do not use if either capsule band or imprinted safety seal under cap is broken or missing Protect from moisture Contains lactose","Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.majorpharmaceuticals.com"],"version":"10","warnings":["Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Do not use to make a child sleepy 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 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 marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful 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 drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children"]}