{"active_ingredient":["Active ingredient (in each tablet) Diphenhydramine HCl 25 mg"],"ask_doctor":["Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma 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 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, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12 years and over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use"],"dosage_and_administration_table":["<table width=\"375px\"><col/><col/><tbody><tr><td styleCode=\" Botrule Toprule Lrule Rrule\">adults and children 12 years and over</td><td styleCode=\" Botrule Toprule Lrule Rrule\">1 to 2 tablets</td></tr><tr><td styleCode=\" Botrule Toprule Lrule Rrule\">children 6 to under 12 years </td><td styleCode=\" Botrule Toprule Lrule Rrule\">1 tablet </td></tr><tr><td styleCode=\" Botrule Toprule Lrule Rrule\">children under 6 years </td><td styleCode=\" Botrule Toprule Lrule Rrule\">do not use</td></tr></tbody></table>"],"effective_time":"20231021","id":"82b4be0a-9425-4eb9-99ab-4ea463dcd500","inactive_ingredient":["Inactive ingredients corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide"],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: itchy, watery eyes sneezing runny nose itching of the nose or throat temporarily relieves these symptoms due to the common cold: sneezing runny 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 (1-800-222-1222) right away."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel ASSURED™ COMPARE TO ACTIVE INGREDIENT OF BENADRYL ® ALLERGY ULTRATAB ® TABLETS * Allergy • Diphenhydramine HCl 25 mg Antihistamine Sneezing, Runny Nose, Itchy Throat, Itchy, Watery Eyes Actual Size 36 tablets TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy ULTRATAB® Tablets. 50844 REV1016D32907 Distributed by: Greenbrier International, Inc. Chesapeake, VA 23320 Assured 44-329 Assured 44-329"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-800-426-9391"],"set_id":"74681d44-6de1-41e5-9f42-4639fa604256","spl_product_data_elements":["Allergy Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE STARCH, CORN D&C RED NO. 27 ALUMINUM LAKE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE 44;329"],"storage_and_handling":["Other information each tablet contains: calcium 30 mg store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from moisture see end flap for expiration date and lot number"],"version":"11","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 glaucoma difficulty in urination due to enlargement of the 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 beverages 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 (1-800-222-1222) right away."],"when_using":["When using this product marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children"]}