{"active_ingredient":["Active ingredient per 5 mL (1 Unit Dose) Diphenhydramine HCl 12.5 mg","Active ingredient per 10 mL (1 Unit Dose) Diphenhydramine HCl 25 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 For the 5 mL Unit-Dose: • 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)","Directions For the 10 mL Unit-Dose: • 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 6 years of age Do not use Children 6 to under 12 years of age 10 mL (25 mg) Adults and children 12 years of age and over 10 mL (25 mg) to 20 mL (50 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)
","
agedose
Children under 6 years of age Do not use
Children 6 to under 12 years of age 10 mL (25 mg)
Adults and children 12 years of age and over 10 mL (25 mg) to 20 mL (50 mg)
"],"effective_time":"20250116","id":"2bd97cb8-2b08-aa8d-e063-6394a90ad19d","inactive_ingredient":["Inactive ingredients 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":["M012"],"brand_name":["Diphenhydramine HCl Oral Solution"],"generic_name":["DIPHENHYDRAMINE HCL ORAL"],"is_original_packager":[true],"manufacturer_name":["Everpharm LLC"],"package_ndc":["84415-013-01","84415-012-01"],"product_ndc":["84415-012","84415-013"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049906"],"spl_id":["2bd97cb8-2b08-aa8d-e063-6394a90ad19d"],"spl_set_id":["d7aaf874-69ac-49cf-93be-6d4a38b9a557"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL EverPharm NDC 84415-012-01 Diphenhydramine HCL Oral Solution Antihistamine 12.5 mg/5 mL • Alcohol Free • Sugar Free • Cherry Flavor For Institutional Use Only 100 x 5 mL Unit-Dose Cups 5label","PRINCIPAL DISPLAY PANEL EverPharm NDC 84415-013-01 Diphenhydramine HCL Oral Solution Antihistamine 25 mg/10 mL • Alcohol Free • Sugar Free • Cherry Flavor For Institutional Use Only 100 x 10 mL Unit-Dose Cups 10label"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? Questions or comments? (866) 838-3774"],"set_id":"d7aaf874-69ac-49cf-93be-6d4a38b9a557","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 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: EverPharm, LLC 14A Winthrop St Marlborough, MA 01752"],"version":"1","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"]}