{"active_ingredient":["ACTIVE INGREDIENT (IN EACH 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 • 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 taking tranquilizers or sedative."],"dosage_and_administration":["Directions Adults and children 12 years and over: take 1 capsule (50mg) every 4 to 6 hours; not more than 6 capsules in 24 hours. Children under 12 years: 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 25mg package."],"effective_time":"20181115","id":"ebb8ddde-654f-4348-9797-6acb4427be34","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 and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose."],"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 HCI Capsules 50mg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["PURPOSE Antihistamine"],"questions":["QUESTIONS? Adverse drug event call: (800) 616-2471 Distributed by: Major ® Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USA M-29 R 12/09"],"set_id":"ac147fc9-d772-4d58-be39-aa1448e7dcd1","spl_product_data_elements":["DIPHENDYDRAMINE HYDROCHLORIDE DIPHENDYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS LACTOSE GELATIN D&C RED NO. 28 FD&C RED NO. 40 FD&C BLUE NO. 1 STARCH, CORN CPC;836"],"spl_unclassified_section":["DRUG FACTS","OTHER INFORMATION • store at controlled room temperature. USP • do not use if either capsule band or imprinted safety seal under cap is broken or missing • protect from excessive moisture • use by expiration date on package • contains lactose"],"version":"11","warnings":["WARNINGS Do not use • with any other products containing diphenhydramine including one applied topically Ask a doctor before use if you have • glaucoma • a breathing problem such as emphysema or chronic bronchitis • difficulty in urination due to enlargement of the prostate gland. Ask a doctor or pharmacist before use if you are taking taking tranquilizers or sedative. 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 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 • use caution when driving a motor vehicle or operating machinery • excitability may occur, especially in children."]}