{"active_ingredient":["Active ingredient (in each 10 mL cup) 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: 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":["<table width=\"100%\"><colgroup><col width=\"50%\"/><col width=\"50%\"/></colgroup><thead><tr><th align=\"left\" styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\">Age (yr)</content></th><th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\">Dose (mL)</content></th></tr></thead><tbody><tr><td styleCode=\"Rrule Toprule \" valign=\"top\"><paragraph>children under 2 years</paragraph></td><td styleCode=\"Toprule Botrule \" valign=\"top\"><paragraph>do not use</paragraph></td></tr><tr><td styleCode=\"Rrule \" valign=\"top\"><paragraph>children 2 to 5 years</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>do not use unless directed by a doctor</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>children 6 to 11 years</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>5 mL to 10 mL</paragraph></td></tr></tbody></table>"],"effective_time":"20240804","id":"1c81b131-ccf6-49a7-e063-6394a90a9695","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":["60687-830-42","60687-830-48","60687-830-56","60687-830-08"],"product_ndc":["60687-830"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049906"],"spl_id":["1c81b131-ccf6-49a7-e063-6394a90a9695"],"spl_set_id":["b94feeb6-f33f-410d-a9b0-776b1ccf34a9"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["Principal Display Panel - Label - 25 mg/10 mL 100 Count Case NDC 60687-830-56, 30 Count Case NDC 60687-830-08 Cup NDC 60687-830-42 Diphenhydramine Hydrochloride Oral Solution USP 25 mg/10 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 10 mL Unit-Dose Cups T0865C100224 R02/24 Diphenhydramine Hydrochloride Oral Solution Label","Principal Display Panel – Cup – 25 mg/10 mL NDC 60687- 830 -42 Diphenhydramine Hydrochloride Oral Solution USP 25 mg/10 mL Antihistamine/Allergy Alcohol Free/Dye Free/Sugar Free Delivers 10 mL Sodium Content: 20 mg/1 O ml See package Drug Facts insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 A0865C100224 25 mg/10 mL Diphenhydramine Hydrochloride Oral Solution Cup Lid"],"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":"b94feeb6-f33f-410d-a9b0-776b1ccf34a9","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":["Drug Facts","Other information each 5 mL contains: sodium 10 mg store between 20-25°C (68-77°F). Diphenhydramine HCl Oral Solution, USP is a clear, cherry flavored liquid supplied in the following: 10 mL unit dose cups: 100 cups (10 x 10) NDC 60687-830-56 10 mL unit dose cups: 30 cups (3 x 10) NDC 60687-830-08"],"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"]}