{"active_ingredient":["Active ingredient (in each banded capsule) Diphenhydramine HCl 25"],"ask_doctor":["Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glucoma • 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 to 6 hours • do not take more than 6 doses in 24 hours adults and children 12 years of age and over 1 to 2 capsules children 6 to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age"],"dosage_and_administration_table":["<table><col/><col/><tbody><tr><td colspan=\"5\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \">adults and children 12 years of age and over </td><td colspan=\"6\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \">1 to 2 capsules</td></tr><tr><td colspan=\"5\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \">children 6 to under 12 years of age</td><td colspan=\"6\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \">1 capsule</td></tr><tr><td colspan=\"5\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \">children under 6 years of age</td><td colspan=\"6\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \">do not use this product in children under 6 years of age</td></tr></tbody></table>"],"effective_time":"20210426","id":"f291a42c-a9ba-4a70-a99b-e044b4c345d3","inactive_ingredient":["Inactive ingredients D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch"],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat 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":{},"package_label_principal_display_panel":["Principal Display Panel Principal Display Panel-Diphenhydramine HCl Capsule 25mg"],"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 Distributed by: MAJOR ® PHARMACEUTICALS 31778 Enterprise Drive Livonia, MI 48150 USA M-29 R05/12"],"set_id":"0b84f3ef-e1bc-464f-b53a-ff5e03ead809","spl_product_data_elements":["Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN ANHYDROUS LACTOSE STARCH, CORN White CPC;835"],"spl_unclassified_section":["Other information • store at room temperature, see USP • do not use if either capsule band or imprinted safety seal under cap is broken or missing • protect from moisture • contains lactose"],"stop_use":[""],"version":"10","warnings":["Warnings 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 • a breathing problem such as emphysema or chronic bronchitis • glucoma • 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"]}