{"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 • a sodium-restricted diet"],"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 • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy"],"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 Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device."],"dosage_and_administration_table":["<table> <col width=\"33%\"/> <col width=\"49%\"/> <tbody> <tr> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>Age (yr)</paragraph> </td> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"> <paragraph>Dose (mL)</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>children under 2 years</paragraph> </td> <td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"middle\"> <paragraph>do not use</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>children 2 to 5 years</paragraph> </td> <td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"> <paragraph>do not use unless directed by a doctor</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>children 6 to 11 years</paragraph> </td> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>5 mL to 10 mL</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20170828","id":"3776b551-632c-40ee-aaac-f8a4acefb3f0","inactive_ingredient":["Inactive ingredients anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution"],"indications_and_usage":["Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing • itching of the nose or throat • runny nose • itchy, watery eyes"],"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":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label Austin/Travis Co. Health & Human Services Dept. Diphenhydramine Soln.118ml Date: Name: Dr. USE AS DIRECTED 1/1/01 123456 Diphenhydramine Sol.12.5mg/5ml #118ml 76413-333-01 Batch: 123456 Lot: 123456 Exp: 1/1/01 SUNMARK Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed. PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"77230b87-90fc-4ed6-b0ab-5671bb4f4eef","spl_product_data_elements":["Diphenhydramine Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID D&C RED NO. 33 FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP POLOXAMER 407 WATER SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL Bluish-Red"],"storage_and_handling":["Other information • each 5 mL contains: sodium 15 mg • store at 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used. • do not use if printed neckband is broken or missing"],"version":"1","warnings":["Warnings Do not use • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy Ask a doctor before use if the child has • a breathing problem such as chronic bronchitis • glaucoma • a sodium-restricted diet Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product • marked drowsiness may occur • excitability may occur, especially in children • sedatives and tranquilizers may increase drowsiness 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 • excitability may occur, especially in children • sedatives and tranquilizers may increase drowsiness"]}