{"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"],"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":["<table width=\"100%\"><col width=\"50%\"/><col width=\"50%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>adults and children 12 years of age and over</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Take 1 capsule (50 mg)</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>children under 12 years of age </paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>ask a doctor, the proper dosage strength is not available in this package**</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>**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.</paragraph></td></tr></tbody></table>"],"effective_time":"20260406","id":"241c4be4-79e6-41e5-a2b3-2cd460d51088","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 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":["341"],"brand_name":["Banophen"],"generic_name":["DIPHENHYDRAMINE HCL"],"manufacturer_name":["Preferred Pharmaceuticals Inc."],"original_packager_product_ndc":["0904-5307"],"package_ndc":["68788-7830-1","68788-7830-3"],"product_ndc":["68788-7830"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020477","1020479"],"spl_id":["241c4be4-79e6-41e5-a2b3-2cd460d51088"],"spl_set_id":["0f52270a-b11a-4fa1-aac2-9fe5ff625419"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Diphenhydramine HCL Capsules USP 50mg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions? Questions or comments? (800) 616-2471"],"set_id":"0f52270a-b11a-4fa1-aac2-9fe5ff625419","spl_product_data_elements":["Banophen diphenhydramine hcl D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED LACTOSE MONOHYDRATE ANHYDROUS LACTOSE STARCH, CORN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CPC;836"],"spl_unclassified_section":["Other Information • Store at room temperature, USP. • 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 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 Repackaged By: Preferred Pharmaceuticals Inc. NDC 68788-7830"],"version":"5","warnings":["WARNINGS Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin"],"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"]}