{"active_ingredient":["Active ingredient (in each 5 mL) Diphenhydramine HCl 12.5 mg"],"dosage_and_administration":[""],"effective_time":"20250430","id":"3404aa22-166f-5501-e063-6394a90a1e7a","inactive_ingredient":["Inactive Ingredients anhydrous citric acid, bubble gum favor, purified water,sodium benzoate, sodium citrate, saccharin sodium, sorbitol solution, sucrose."],"indications_and_usage":["Directions do not take more than 6 doses in any 24 hours take every 4 to 6 hours, or as directed by a doctor mL = milliliter keep dosing cup with product find the right dose on the chart below Age (yr) Dose (mL) children 6 to 11 years 5 mL to 10 mL children 2 to 5 years Do not use unless directed by a doctor children under 2 years Do not use"],"indications_and_usage_table":["<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"600px\"><tbody><tr><td><paragraph><content styleCode=\"bold\"> Age (yr)</content></paragraph></td><td><paragraph><content styleCode=\"bold\"> Dose (mL)</content></paragraph></td></tr><tr><td><paragraph> children 6 to 11 years </paragraph></td><td><paragraph> 5 mL to 10 mL</paragraph></td></tr><tr><td><paragraph> children 2 to 5 years </paragraph></td><td><paragraph> Do not use unless directed by a doctor</paragraph></td></tr><tr><td><paragraph> children under 2 years </paragraph></td><td><paragraph> Do not use</paragraph></td></tr></tbody></table>"],"keep_out_of_reach_of_children":[""],"openfda":{"application_number":["M012"],"brand_name":["DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML"],"generic_name":["DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML"],"is_original_packager":[true],"manufacturer_name":["AARNA USA INC."],"nui":["N0000000190","N0000175587"],"package_ndc":["82568-0016-4","82568-0016-8","82568-0016-6"],"pharm_class_epc":["Histamine-1 Receptor Antagonist [EPC]"],"pharm_class_moa":["Histamine H1 Receptor Antagonists [MoA]"],"product_ndc":["82568-0016"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049906"],"spl_id":["3404aa22-166f-5501-e063-6394a90a1e7a"],"spl_set_id":["32c26835-f54e-d7e5-e063-6294a90ae1c0"],"substance_name":["DIPHENHYDRAMINE"],"unii":["8GTS82S83M"]},"other_safety_information":["Other Information each 5 mL contains: sodium 8 mg Store between 20°- 25°C (68°-77°F). Do not refrigerate protect from light"],"package_label_principal_display_panel":["2","3","4","7","5"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? Please Call 1(877) 225-6999 Manufactured for: AARNA USA INC Leland, NC 28451 *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy"],"set_id":"32c26835-f54e-d7e5-e063-6294a90ae1c0","spl_product_data_elements":["DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML WATER SODIUM BENZOATE SORBITOL SOLUTION SODIUM SACCHARIN SODIUM CITRATE ANHYDROUS CITRIC ACID SUCROSE DIPHENHYDRAMINE DIPHENHYDRAMINE"],"version":"3","warnings":["Warnings Do not use with any other product containing diphenhydramine, even one used on skin to make a child sleepy Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a sodium restricted diet Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers. When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitabillty may occur, especially in 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."],"when_using":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itchy of the nose or throat"]}