{"active_ingredient":["Active ingredient (in each 5 mL) Diphenhydramine HCl 12.5 mg"],"ask_doctor":["Ask a doctor before use if the child has glaucoma a breathing problem such as chronic bronchitis"],"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 do not take more than directed do not take more than 6 doses in 24 hours mL = milliliter only use the dose cup provided find right dose on chart below take every 4 to 6 hours, or as directed by a doctor 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 cellspacing=\"0\" cellpadding=\"0\"><col/><col/><tbody><tr><td styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">Age (yr)</content></td><td styleCode=\" Botrule\"><content styleCode=\"bold\">Dose (mL)</content></td></tr><tr><td styleCode=\" Botrule Rrule\">children under 2 years </td><td styleCode=\" Botrule\">do not use </td></tr><tr><td styleCode=\" Botrule Rrule\">children 2 to 5 years</td><td styleCode=\" Botrule\"><paragraph>do not use unless   directed by a doctor </paragraph></td></tr><tr><td styleCode=\" Rrule\">children 6 to 11 years </td><td>5 mL to 10 mL </td></tr></tbody></table>"],"effective_time":"20260408","id":"75d2b34d-b2db-45e0-8e14-e951bba04c13","inactive_ingredient":["Inactive ingredients anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum"],"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."],"openfda":{"application_number":["M012"],"brand_name":["Childrens Allergy Relief"],"generic_name":["DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["Cardinal Health 110, LLC. DBA Leader"],"package_ndc":["70000-0701-1"],"product_ndc":["70000-0701"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049906"],"spl_id":["75d2b34d-b2db-45e0-8e14-e951bba04c13"],"spl_set_id":["d2dab450-cf82-4be2-a4e2-630295fb59ab"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0096295144208"]},"package_label_principal_display_panel":["Principal Display Panel LEADER ™ NDC 70000-0701-1 DYE-FREE Children's Allergy Relief Diphenhydramine HCl 12.5 mg / 5 mL Oral Solution Antihistamine Clear Bubble Gum Flavored Liquid Ages 6 to 11 Years Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Alcohol-Free Sugar-Free COMPARE TO CHILDREN’S BENADRYL® DYE-FREE ALLERGY LIQUID active ingredient* 100% Money Back Guarantee 4 FL OZ (118 mL) *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Children’s Benadryl® Dye-Free Allergy. 50844 ORG072401836 ©2024 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Cardinal Health™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 All LEADER™ Brand Products Have A 100% Money Back Guarantee Return to place of purchase if not satisfied. CIN 5922232 REV. 06/24 LEADER 44-018 LEADER 44-018"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-800-426-9391"],"set_id":"d2dab450-cf82-4be2-a4e2-630295fb59ab","spl_product_data_elements":["Childrens Allergy Relief Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CHLORIDE TRISODIUM CITRATE DIHYDRATE SUCRALOSE XANTHAN GUM"],"storage_and_handling":["Other information each 5 mL contains: sodium 4 mg store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number"],"version":"3","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 glaucoma a breathing problem such as chronic bronchitis 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."],"when_using":["When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children"]}