{"active_ingredient":["Active ingredient (in each 5 mL) Diphenhydramine HCl USP 12.5 mg","Active ingredient (in each 10 mL) Diphenhydramine HCl USP 25 mg"],"ask_doctor":["Ask a doctor before use if you have • glaucoma • a breathing problem such as emphysema or chronic bronchitis • a sodium restricted diet • trouble urinating due to enlarged prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives"],"do_not_use":["Do not use • in neonates or premature infants • if pregnant or breast-feeding • if hypersensitive to diphenhydramine HCI and other similar antihistamine • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy"],"dosage_and_administration":["Directions • Use the following dosage guidelines when using this product Age (yr) Dose (mL) Adults and children 12 years and older take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours. Children 6 years to under 12 years take 5 mL every 4 to 6 hours; not more than 30 mL in 24 hours Children under 6 years ask a doctor"],"dosage_and_administration_table":["
Age (yr)Dose (mL)
Adults and children 12 years and oldertake 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours.
Children 6 years to under 12 yearstake 5 mL every 4 to 6 hours; not more than 30 mL in 24 hours
Children under 6 yearsask a doctor
"],"effective_time":"20231101","how_supplied":["How Supplied Each 5 mL of Diphenhydramine Hydrochloride Oral Solution, USP contains 12.5mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms: NDC 69339-151-05 (1) unit dose cup 5mL NDC 69339-151-17 40 (4x10) unit dose cups 5mL NDC 69339-151-19 100 (10x10) unit dose cups 5mL Each 10 mL of Diphenhydramine Hydrochloride Oral Solution, USP contains 25mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms: NDC 69339-152-01 (1) unit dose cup 10mL NDC 69339-152-17 40 (4x10) unit dose cups 10mL NDC 69339-152-19 100 (10x10) unit dose cups 10mL"],"id":"6c998d25-3573-4c6b-822a-1c16eeddd642","inactive_ingredient":["Inactive ingredients Citric acid, D&C Red No. 33, FD&C Red No. 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, and sucrose."],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy 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 Oral Solution"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Natco Pharma USA LLC"],"package_ndc":["69339-151-05","69339-151-17","69339-151-19","69339-152-01","69339-152-17","69339-152-19"],"product_ndc":["69339-151","69339-152"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049906"],"spl_id":["6c998d25-3573-4c6b-822a-1c16eeddd642"],"spl_set_id":["54b64354-ac10-42ff-a53d-96cef933a91a"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0369339152010","0369339151051"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Delivers 5 mL NDC 69339-151-05 Diphenydramine HCl Oral Solution, USP 12.5 mg/5 mL For Institutional Use Only 3 69339 15105 1 Lot # 000000 Exp: MM/YYY See Insert DASH Pharmaceuticals LLC Upper Saddle River, NJ 07458 DASH- DOSE Principal Display Panel","PRINCIPAL DISPLAY PANEL Delivers 10 mL NDC 69339-152-01 Diphenydramine HCl Oral Solution, USP 25 mg/10 mL For Institutional Use Only 3 69339 15201 0 Lot # 000000 Exp: MM/YYY See Insert DASH Pharmaceuticals LLC Upper Saddle River, NJ 07458 DASH- DOSE Principal Display Panel"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? Call 201-786-6500 Dash Pharmaceuticals LLC Upper Saddle River, NJ 07458 DP-UD-PI-AT-[117894] Rev 08/20"],"set_id":"54b64354-ac10-42ff-a53d-96cef933a91a","spl_product_data_elements":["Diphenhydramine HCl Oral Solution diphenhydramine hydrochloride ANHYDROUS CITRIC ACID GLYCERIN WATER SUCROSE SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM D&C RED NO. 33 FD&C RED NO. 40 POLOXAMER 407 SODIUM CHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE Diphenhydramine HCl Oral Solution diphenhydramine hydrochloride ANHYDROUS CITRIC ACID GLYCERIN WATER SUCROSE SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM D&C RED NO. 33 FD&C RED NO. 40 POLOXAMER 407 SODIUM CHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE"],"spl_unclassified_section":["Drug Facts","Other information • each 5mL contains sodium 10mg • each 10mL contains sodium 20mg • alcohol free, cherry flavor • store at 20-25°C (68-77°F) • protect from excessive moisture • do not use if lid seal is open or damaged • see top of cup for lot number and expiration date"],"version":"6","warnings":["Warnings Do not use • in neonates or premature infants • if pregnant or breast-feeding • if hypersensitive to diphenhydramine HCI and other similar antihistamine • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy Ask a doctor before use if you have • glaucoma • a breathing problem such as emphysema or chronic bronchitis • a sodium restricted diet • trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives When using this product • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • 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 • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children"]}