{"active_ingredient":["Active ingredient (in each 5 mL) Diphenhydramine HCl 12.5 mg"],"ask_doctor":["Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma"],"do_not_use":["Do no use to make a child sleepy with any other product containing diphenhydramine, even one used on skin"],"dosage_and_administration":["Directions: find right dose on chart below mL = milliliter take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours Age (yr) Dose (mL) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 mL to 10 mL"],"dosage_and_administration_table":["<table><col/><col/><thead><tr><th styleCode=\" Botrule Toprule Lrule Rrule\"> Age (yr)</th><th valign=\"top\" styleCode=\" Botrule Toprule Lrule Rrule\"> Dose (mL)</th></tr></thead><tbody><tr><td valign=\"top\" styleCode=\" Botrule Toprule Lrule Rrule\">children under 2 years</td><td valign=\"top\" styleCode=\" Botrule Toprule Lrule Rrule\">do not use</td></tr><tr><td valign=\"top\" styleCode=\" Botrule Toprule Lrule Rrule\">children 2 to 5 years</td><td valign=\"top\" styleCode=\" Botrule Toprule Lrule Rrule\">do not use unless directed by a doctor</td></tr><tr><td valign=\"top\" styleCode=\" Botrule Toprule Lrule Rrule\">children 6 to 11 years</td><td valign=\"top\" styleCode=\" Botrule Toprule Lrule Rrule\">5 mL to 10 mL</td></tr></tbody></table>"],"effective_time":"20250801","id":"45b07e82-0ce9-492f-8303-65c992c7dc32","inactive_ingredient":["Inactive ingredients: citric acid anhydrous, glycerin, flavoring, purified water, saccharin sodium, sodium benzoate, sodium carboxymethylcellulose, sodium citrate, sorbitol."],"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"],"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. (1-800-222-1222)"],"openfda":{"application_number":["M012"],"brand_name":["Diphenhydramine HCl"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"manufacturer_name":["Major Pharmaceuticals"],"original_packager_product_ndc":["0121-0865","0121-1730"],"package_ndc":["0904-7560-41","0904-7560-70","0904-7559-66","0904-7559-72"],"product_ndc":["0904-7559","0904-7560"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049906"],"spl_id":["45b07e82-0ce9-492f-8303-65c992c7dc32"],"spl_set_id":["1b591e27-b00b-41c8-9fe9-c633aba09134"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0309047559664","0309047560417"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Delivers 5 mL NDC0904-7560-41 Diphenydramine HCl Oral Solution USP 12.5 mg/5 mL Lidding for Diphenhydramine HCl Oral Solution USP 5 mL UD Cup","PRINCIPAL DISPLAY PANEL Delivers 10 mL NDC0904-7559-66 Diphenydramine HCl Oral Solution USP 25 mg/10 mL Lidding for Diphenhydramine HCl Oral Solution USP 10 mL UD Cup"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? Call 1-800-845-8210 R02/25 Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268"],"set_id":"1b591e27-b00b-41c8-9fe9-c633aba09134","spl_product_data_elements":["Diphenhydramine HCl diphenhydramine hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID GLYCERIN WATER SACCHARIN SODIUM SODIUM BENZOATE CARBOXYMETHYLCELLULOSE SODIUM SODIUM CITRATE, UNSPECIFIED FORM SORBITOL CLEAR Diphenhydramine HCl diphenhydramine hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID GLYCERIN WATER SACCHARIN SODIUM SODIUM BENZOATE CARBOXYMETHYLCELLULOSE SODIUM SODIUM CITRATE, UNSPECIFIED FORM SORBITOL CLEAR"],"spl_unclassified_section":["Drug Facts","Other information each 5 mL contains: sodium 10 mg store between 20° to 25°C (68° to 77°F). Diphenhydramine HCl Oral Solution, USP is a clear, cherry flavored liquid supplied in the following: NDC 0904-7560-41: 5 mL unit dose cup, in a tray of 10 cups. NDC 0904-7559-66: 10 mL unit dose cup, in a tray of 10 cups."],"version":"2","warnings":["Warnings Do no use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma 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 excitability may occur, especially in children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"],"when_using":["When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children"]}