{"active_ingredient":["Active ingredient (in each softgel) Diphenhydramine HCl 25 mg"],"dosage_and_administration":["Directions •take only one dose per day (24 hours) adults and children 12 years and over take 2 softgels at bedtime if needed or as directed by a doctor children under 12 years do not use"],"dosage_and_administration_table":["<table width=\"50%\"><tbody><tr><td styleCode=\"Botrule Rrule\"> adults and children 12 years and over</td><td styleCode=\"Botrule\"> take 2 softgels at bedtime if needed or as directed by a doctor</td></tr><tr><td styleCode=\"Rrule\" align=\"left\"> children under 12 years</td><td> do not use</td></tr></tbody></table>"],"effective_time":"20240111","id":"c2495666-a137-4697-be2d-d905f7294746","inactive_ingredient":["Inactive ingredients edible white ink, FD&C blue#1, FD&C red#40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution"],"indications_and_usage":["Uses •for relief of occasional sleeplessness •reduces time to fall asleep if you have difficulty falling asleep"],"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":["M010"],"brand_name":["Sleep-Aid Diphenhydramine HCl"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Cardinal Health 110, LLC. DBA Leader"],"package_ndc":["70000-0584-1"],"product_ndc":["70000-0584"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049909"],"spl_id":["c2495666-a137-4697-be2d-d905f7294746"],"spl_set_id":["4283558d-62df-4297-bc85-a4e06681a920"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["Packaging Cardi-1"],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions or comments? 1-888-577-8033 Monday-Friday 8am-4pm EST"],"set_id":"4283558d-62df-4297-bc85-a4e06681a920","spl_product_data_elements":["Sleep-Aid Diphenhydramine HCl Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN ISOPROPYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED WATER SORBITOL SORBITAN oblong 779"],"spl_unclassified_section":["Drug Facts","LEADER ™ Non-Habit Forming Not for Treating Pain, Cold or Flu COMPARE TO VICKS ® ZZZQUIL ® NIGHTTIME SLEEP-AID LIQUICAPS ® active ingredient* 100% Money Back Guarantee *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark VICKS ® ZzzQuil ® NIGHTTIME SLEEP-AID LiquiCaps ® . All LEADER TM Brand Products Have A 100% Money Back Guarantee Return to place of purchase if not satisfied. READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION Cardinal Health ™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 ©2021 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. Product of UAE Packaged and Quality Assured in the USA TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING"],"storage_and_handling":["Other information •store at 20-25°C (68-77°F) •avoid excessive heat above 40°C (104°F) •protect from light"],"version":"3","warnings":["Warnings Do not use •for children under 12 years of age •with any other product containing diphenhydramine, even one used on skin •with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products Ask a doctor before use if you have •glaucoma •heart diseases •a breathing problem such as emphysema, asthma, or chronic bronchitis •difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers, or any other sleep aid When using this product •avoid alcoholic beverages and other drugs that cause drowsiness. Be careful when driving a motor vehicle or operating machinery. Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. 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."]}