{"active_ingredient":["Active ingredient (in each softgel) Diphenhydramine HCl 25 mg"],"dosage_and_administration":["Directions •take every 4 to 6 hours, or as directed by a doctor •do not take more than 6 doses in 24 hours adults and children 12 years and older 1 to 2 softgels children 6 to under 12 years 1 softgel children under 6 years do not use"],"dosage_and_administration_table":["<table width=\"50%\"><tbody><tr><td styleCode=\"Botrule Rrule\">adults and children 12 years and older</td><td styleCode=\"Botrule\" align=\"right\"> 1 to 2 softgels</td></tr><tr><td styleCode=\"Botrule Rrule\">children 6 to under 12 years</td><td styleCode=\"Botrule\" align=\"right\"> 1 softgel</td></tr><tr><td styleCode=\"Rrule\">children under 6 years</td><td align=\"right\"> do not use</td></tr></tbody></table>"],"effective_time":"20240111","id":"7bc485c5-63d3-4060-af39-cc081de1d135","inactive_ingredient":["Inactive ingredients edible white ink, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution"],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: •runny nose •itchy,watery eyes •sneezing •itching of the nose or throat temporarily relieves these symptoms due to the common cold: •runny nose •sneezing"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["Allergy Relief Diphenhydramine HCl"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Cardinal Health 110, LLC. DBA Leader"],"package_ndc":["70000-0585-1"],"product_ndc":["70000-0585"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049909"],"spl_id":["7bc485c5-63d3-4060-af39-cc081de1d135"],"spl_set_id":["ad437177-08eb-4811-883f-ac543d5bc58c"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["Packaging Cardi-0585-1"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-888-577-8033 Monday-Friday 8am-4pm EST"],"set_id":"ad437177-08eb-4811-883f-ac543d5bc58c","spl_product_data_elements":["Allergy Relief Diphenhydramine HCl Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE GELATIN, UNSPECIFIED GLYCERIN ISOPROPYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED WATER SORBITOL SORBITAN pale yellow transparent oblong 780"],"spl_unclassified_section":["Drug Facts","LEADER ™ DYE-FREE Relief of: Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Throat COMPARE TO BENADRYL ® DYE-FREE ALLERGY active ingredient* 100% Money Back Guarantee READ AND KEEP OUTER PACKAGE FOR COMPLETE WARNINGS AND PRODUCT INFORMATION *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl ® Dye-Free Allergy. All LEADER TM Brand Products Have A 100% Money Back Guarantee Return to place of purchase if not satisfied. DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Product of UAE Packaged and Quality Assured in the USA ©2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, 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 BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING"],"storage_and_handling":["Other information •store at 25°C (77°F) in a dry place •protect from light, heat and moisture"],"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 you have •a breathing problem such as emphysema or chronic bronchitis •glaucoma •difficulty in urination due to enlargement to the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product •marked drowsiness may occur •avoid alcoholic beverages •alcohol, sedatives, and tranquilizers may increase drowsiness •use caution when driving a motor vehicle or operating machinery •excitability may occur, especially in children If pregnant or breast-feeding , ask a health professional before use Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."]}