{"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 trouble urinating due to an enlarged prostate gland glaucoma"],"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 tablets children 6 to under 12 years of age 1 tablet children under 6 years of age do not use this product in children under 6 years of age"],"dosage_and_administration_table":["<table width=\"60%\" styleCode=\"Noautorules\"><col width=\"50%\" valign=\"top\" align=\"left\"/><col width=\"50%\" valign=\"top\" align=\"left\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">adults and children 12 years of age and over</td><td>1 to 2 tablets</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">children 6 to under 12 years of age</td><td>1 tablet</td></tr><tr><td styleCode=\"Rrule\">children under 6 years of age</td><td>do not use this product in children under 6 years of age</td></tr></tbody></table>"],"effective_time":"20241219","id":"29a7bbb5-a640-edae-e063-6294a90aa233","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C red # 27 Al lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide"],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing 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 - 25 mg Tablet Bottle Carton ASSURED ™ COMPARE TO ACTIVE INGREDIENT OF BENADRYL ® ALLERGY ULTRATAB ® * Allergy Diphenhydramine HCl 25 mg Antihistamine Sneezing, Runny Nose, Itchy Throat, Itchy, Watery Eyes Actual Size 36 tablets Principal Display Panel - 25 mg Tablet Bottle Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-888-333-9792"],"set_id":"ec0863eb-2a59-4968-b96e-a3b02b1f241b","spl_product_data_elements":["Assured Allergy Relief Diphenhydramine Hydrochloride SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C RED NO. 27 ANHYDROUS DIBASIC CALCIUM PHOSPHATE LECITHIN, SOYBEAN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYVINYL ALCOHOL, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE WATER DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE S4"],"spl_unclassified_section":["Drug Facts","DISTRIBUTED BY GREENBRIER INTERNATIONAL, INC. 500 VOLVO PARKWAY, CHESAPEAKE, VA 23320"],"storage_and_handling":["Other information store at controlled room temperature 15°-30° C (59°-86° F) protect from moisture and light see end flap for expiration date and lot number each tablet contains calcium 24 mg"],"version":"8","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 trouble urinating due to an enlarged prostate gland glaucoma 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"]}