{"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":["
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)
","
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)
"],"effective_time":"20250904","id":"425e484b-f7c7-4776-8d72-9a5bfb4f6dc5","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":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL MAJOR® NDC 0904-7323-41 Each 5 mL Contains: Diphenhydramine HCL Oral Solution 12.5 mg/5 mL Antihistamine Delivers 5 mL • See insert For Institutional Use Only Cherry Flavor MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 Sugar Free • Alcohol Free 5mLPrincipalDisplay","PRINCIPAL DISPLAY PANEL MAJOR® NDC 0904-7324-66 Each 10 mL Contains: Diphenhydramine HCL Oral Solution 25 mg/10 mL Antihistamine Delivers 10 mL • See insert For Institutional Use Only Cherry Flavor MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 Sugar Free • Alcohol Free 10mLPrincipalDisplay"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? (855) 879-4368"],"set_id":"0f9015c9-a95a-5703-e063-6394a90a6ad2","spl_product_data_elements":["Diphenhydramine HCl Oral Solution Diphenhydramine HCl Oral DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CITRIC ACID MONOHYDRATE FD&C RED NO. 40 METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE Diphenhydramine HCl Oral Solution Diphenhydramine HCl Oral DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CITRIC ACID MONOHYDRATE FD&C RED NO. 40 METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE"],"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: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471"],"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"]}