{"active_ingredient":["Active ingredient per 5 mL (1 Unit Dose) Diphenhydramine HCl 12.5 mg"],"ask_doctor":["Ask a doctor before use if the child has • a breathing problem such as chronic bronchitis • glaucoma"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if the child is 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 physician • do not take more than 6 doses in 24 hours age dose Children under 2 years of age Do not use Children 2 to under 6 years of age Do not use unless directed by a doctor Children 6 to under 12 years of age 5 mL (12.5 mg) to 10 mL (25 mg)"],"dosage_and_administration_table":["
agedose
Children under 2 years of ageDo not use
Children 2 to under 6 years of ageDo not use unless directed by a doctor
Children 6 to under 12 years of age5 mL (12.5 mg) to 10 mL (25 mg)
"],"effective_time":"20250701","id":"1478d628-1d0d-491f-b68f-5281dd2ced76","inactive_ingredient":["Inactive ingredients: citric acid, flavor, FD&C red#40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose"],"indications_and_usage":["Uses • Temporarily relieves these symptoms due to hay fever or other 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 accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)"],"openfda":{"application_number":["M009.50"],"brand_name":["Diphenhydramine HCl Oral Solution"],"generic_name":["DIPHENHYDRAMINE HCL ORAL"],"is_original_packager":[true],"manufacturer_name":["Rising Pharma Holdings, Inc."],"package_ndc":["57237-317-05","57237-317-51"],"product_ndc":["57237-317"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049906"],"spl_id":["1478d628-1d0d-491f-b68f-5281dd2ced76"],"spl_set_id":["7406e4e4-3093-4cd1-80ce-93f7b6db2a87"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0357237317518"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL 12.5 mg/5 mL Case Label NDC 57237-317-51 Lid Label NDC 57237-317-05 Diphenhydramine-Case-lab Diphenhydramine-Lid-lab"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? Call 1-844-474-7464"],"set_id":"7406e4e4-3093-4cd1-80ce-93f7b6db2a87","spl_product_data_elements":["Diphenhydramine HCl Oral Solution Diphenhydramine HCl Oral CITRIC ACID MONOHYDRATE FD&C RED NO. 40 METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN SODIUM CITRATE SUCRALOSE WATER DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE"],"spl_unclassified_section":["Drug Facts","Other information • each 5 mL contains sodium: 3 mg • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] • do not use if lid is torn or broken","Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 FG-35/Iss.: 10/2023","NDC Information - 12.5 mg/5 mL Each 5 mL of Diphenhydramine HCl Oral Solution contains Diphenhydramine HCl 12.5 mg and is supplied in the following oral dosage forms: NDC 57237-317-05: 5 mL unit dose cup NDC 57237-317-51: 100 x 5 mL Unit-Dose Cups"],"version":"3","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 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 accidental 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"]}