{"active_ingredient":["Active ingredient (in each tablet) Diphenhydramine HCl 25 mg"],"ask_doctor_or_pharmacist":["Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty in urination due to an enlargement of the prostate gland","Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives."],"dosage_and_administration":["Directions • take every 4 to 6 hours, not more than 6 doses in 24 hours adults and children 12 years of age and over take 1 or 2 tablets children 6 to under 12 years of age take 1 tablet children under 6 years of age consult a doctor children under 4 years of age do not use"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"61%\"/><col width=\"38%\"/><tbody><tr><td styleCode=\"Toprule \" valign=\"top\"><paragraph> adults and children 12 years of age and over</paragraph></td><td styleCode=\"Toprule \" valign=\"top\"><paragraph> take 1 or 2 tablets</paragraph></td></tr><tr><td valign=\"top\"><paragraph> children 6 to under 12 years of age</paragraph></td><td valign=\"top\"><paragraph> take 1 tablet</paragraph></td></tr><tr><td valign=\"top\"><paragraph> children under 6 years of age</paragraph></td><td valign=\"top\"><paragraph> consult a doctor </paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"><paragraph>children under 4 years of age </paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">do not use</content> </paragraph></td></tr></tbody></table>"],"effective_time":"20250407","id":"87a4749b-be63-42a5-8a16-50d3c8bc839e","inactive_ingredient":["Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, DandC Red 27Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, polyvinyl alcohol*, purified water*, talc*, and titanium dioxide * contains one or more of these ingredients Questions or comments? *This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl Allergy Ultratabs."],"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":{},"other_safety_information":["Other information • each tablet contains: calcium 25 mg/tablet • store at room temperature 15°-30°C (59°-86°F) • protect from light and moisture"],"package_label_principal_display_panel":["Package/Label Principal Display Panel NDC 63548-0070-1 *Compare to the active ingredient in Benadryl® Allergy Ultratabs® Antihistamine Allergy Tablets Diphenhydramine Hydrochloride 25 mg For Allergy Relief Sneezing, Itchy, Watery Eyes, Runny Nose, Itchy Throat 12 Tablets THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION Allergy Tablets Packaging Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? *This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl Allergy Ultratabs."],"set_id":"716d0321-fa5e-45c1-9a49-6476453e57a4","spl_product_data_elements":["Leader allergy Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C RED NO. 27 DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 POLYSORBATE 80 POLYVINYL ALCOHOL, UNSPECIFIED TALC TITANIUM DIOXIDE dark T61;V25;EL"],"version":"4","warnings":["Warnings Do not use • 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 an enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product • excitability may occur, especially in children • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • use caution when operating machinery or driving a motor vehicle 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 • excitability may occur, especially in children • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • use caution when operating machinery or driving a motor vehicle"]}