{"active_ingredient":["Active ingredient (in each 5 mL = 1 teaspoon) Diphenhydramine, USP 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.","Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product. Age (yr) Dose (TSP) TSP = teaspoon under 6 yrs. ask a doctor 6 to under 12 1-2 TSP or as directed by a doctor"],"ask_doctor_or_pharmacist_table":["<table width=\"50%\"> <col width=\"45%\" align=\"center\" valign=\"middle\"/> <col width=\"55%\" align=\"center\" valign=\"middle\"/> <thead> <tr styleCode=\"Botrule\"> <th styleCode=\"Lrule Rrule\">Age (yr)</th> <th styleCode=\"Rrule\">Dose (TSP)</th> </tr> </thead> <tfoot> <tr> <td colspan=\"2\" align=\"left\">TSP = teaspoon</td> </tr> </tfoot> <tbody> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule Rrule\">under 6 yrs.</td> <td styleCode=\"Rrule\">ask a doctor</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule Rrule\">6 to under 12</td> <td styleCode=\"Rrule\">1-2 TSP</td> </tr> <tr> <td colspan=\"2\" styleCode=\"Lrule Rrule\">or as directed by a doctor</td> </tr> </tbody> </table>"],"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 may be given every 4 to 6 hours do not use more than 6 times in 24 hours use only enclosed dosing cup to dose this product. Do not use any other dosing device."],"effective_time":"20130206","id":"f8c91261-b067-4bea-810b-6b28dc893b0e","inactive_ingredient":["Inactive ingredients artificial flavor, citric acid anhydrous, CMC sodium, glycerin, polysorbate, propylene glycol, purified water, sodium benzoate, sodium saccharin, sodium citrate dihydrate, sorbitol solution."],"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."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label ACCU DIAL ® Children's Allergy Diphenhydramine HCl Oral Solution Antihistamine Relieves Sneezing • Itchy, Watery Eyes Runny Nose • Itchy Throat Earth-Friendly Package! For Ages 6 yrs to under 12 yrs Tamper Evident Compares to Children's Benadryl® Allergy Dye-Free BUBBLEGUM FLAVOR NDC 45014-161-04 4 FL. OZ. (118 mL) PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label"],"purpose":["Purpose Antihistamine"],"questions":["Questions? 877-434-2036"],"set_id":"cb18f535-1876-4d1b-962a-a9fde8f180bb","spl_product_data_elements":["Allergy Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride Diphenhydramine Anhydrous Citric Acid Sodium Glycerin Polysorbate 20 Propylene Glycol Water Sodium Benzoate Saccharin Sodium Trisodium Citrate Dihydrate Sorbitol"],"spl_unclassified_section":["Drug Facts","Distributed by: AccuDial® Pharmaceutical, Inc. Palm Beach Gardens, FL 33408"],"storage_and_handling":["Other information each teaspoon contains: sodium 7 mg store between 20°-25°C (68°-77°F) tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing."],"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 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 sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children. Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product. Age (yr) Dose (TSP) TSP = teaspoon under 6 yrs. ask a doctor 6 to under 12 1-2 TSP or as directed by a doctor Keep out of reach of children. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms."],"warnings_table":["<table width=\"50%\"> <col width=\"45%\" align=\"center\" valign=\"middle\"/> <col width=\"55%\" align=\"center\" valign=\"middle\"/> <thead> <tr styleCode=\"Botrule\"> <th styleCode=\"Lrule Rrule\">Age (yr)</th> <th styleCode=\"Rrule\">Dose (TSP)</th> </tr> </thead> <tfoot> <tr> <td colspan=\"2\" align=\"left\">TSP = teaspoon</td> </tr> </tfoot> <tbody> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule Rrule\">under 6 yrs.</td> <td styleCode=\"Rrule\">ask a doctor</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule Rrule\">6 to under 12</td> <td styleCode=\"Rrule\">1-2 TSP</td> </tr> <tr> <td colspan=\"2\" styleCode=\"Lrule Rrule\">or as directed by a doctor</td> </tr> </tbody> </table>"],"when_using":["When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children."]}