{"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"],"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: 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":["
Age (yr)Dose (mL)
children under 2 yearsdo not use
children 2 to 5 yearsdo not use unless directed by a doctor
children 6 to 11 years5 mL to 10 mL
"],"effective_time":"20240804","id":"1d639138-d6a9-588b-e063-6394a90a2bb9","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"],"is_original_packager":[true],"manufacturer_name":["American Health Packaging"],"package_ndc":["60687-829-40","60687-829-46","60687-829-86"],"product_ndc":["60687-829"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049906"],"spl_id":["1d639138-d6a9-588b-e063-6394a90a2bb9"],"spl_set_id":["4cd8aee3-5522-434b-a1b1-9591bed3e9a6"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["Principal Display Panel - Label 100 Count Case NDC 60687-829-86 Cup NDC 60687-829-40 Diphenhydramine Hydrochloride Oral Solution USP 12.5 mg/5 mL Antihistamine/Allergy Alcohol Free/Dye Free/Sugar Free Usual Dosage: See attached Drug Facts Store at 20° to 25°C (68° to 77°F) For Institutional Use Only 10 x 5 mL Unit-Dose Cups T0865C050224 R02/24 Diphenhydramine Hydrochloride Oral Solution USP Label","Principal Display Panel – Cup – 12.5 mg/5 mL NDC 60687- 829 -40 Diphenhydramine Hydrochloride Oral Solution USP 12.5 mg/5 mL Antihistamine/Allergy Alcohol Free/Dye Free/Sugar Free Delivers 5 mL Sodium Content: 10 mg/5 ml See package Drug Facts insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 A0865C050224 12.5 mg/5 mL Diphenhydramine Hydrochloride Oral Solution USP Cup Label"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? Call 1-800-845-8210 DO NOT USE IF SEAL IS BROKEN. Distributed by: American Health Packaging Columbus, OH 43217 R02/24"],"set_id":"4cd8aee3-5522-434b-a1b1-9591bed3e9a6","spl_product_data_elements":["Diphenhydramine HCl Diphenhydramine Hydrochloride ANHYDROUS CITRIC ACID GLYCERIN WATER SACCHARIN SODIUM SODIUM BENZOATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SODIUM CITRATE, UNSPECIFIED FORM SORBITOL DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CLEAR"],"spl_unclassified_section":["Other information each 5 mL contains: sodium 10 mg store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used. Diphenhydramine HCl Oral Solution, USP is a clear, cherry flavored liquid supplied in the following: 5 mL unit dose cups: 100 cups (10 x 10) NDC 60687-829-86"],"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 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"]}