{"active_ingredient":["Active ingredient (in each 30 mL dose cup) Diphenhydramine HCl 50 mg"],"ask_doctor":["Ask a doctor before use if you have a breathing problem such as asthma, emphysema, or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland heart disease"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep- aid."],"do_not_use":["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"],"dosage_and_administration":["Directions take only one dose per day (24 hours) – see Overdose warning Measure with dosing cup provided. adults & children 12 yrs & over One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor Children under 12 yrs Do not use"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"20%\"/><col width=\"80%\"/><tbody><tr><td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"/><td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"/></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>adults &amp; children 12 yrs &amp; over</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>Children under 12 yrs</paragraph></td><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>Do not use</paragraph></td></tr></tbody></table>"],"effective_time":"20251014","id":"411d2a1e-9828-3e33-e063-6294a90a8a9e","inactive_ingredient":["Inactive ingredients anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum. Questions or comments? 1-866-467-2748"],"indications_and_usage":["Uses for the 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."],"openfda":{"application_number":["M010"],"brand_name":["LEADER Nighttime Sleep-Aid"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["CARDINAL HEALTH"],"package_ndc":["70000-0174-1"],"product_ndc":["70000-0174"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1248354"],"spl_id":["411d2a1e-9828-3e33-e063-6294a90a8a9e"],"spl_set_id":["68c79c47-11bf-4b51-ace0-723cac7a4620"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL LEADER NDC 70000-0174-1 Nighttime Sleep-aid Diphenhydramine HCl COMPARE TO ZZZQUIL ® active ingredient* 100% money Back Guarantee Non-habit forming Berry flavor Naturally & Artificially Flavored Non-habit forming 12 FL OZ (354 mL) ©2016 Cardinal Health, All Rights Reserved CARDINAL HEALTH, the Cardinal Health LOGO,LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal health. Failure to follow these warnings could result in serious consequences. TAMPER EVIDENT: Do not use if printed shrink band is missing or broken DISTRIBUTED BY: CARDINAL HEALTH DUBLIN,OHIO 43017 www.myleader.com 1-800-200-6313 *This product is not manufactured or distributed by Procter & Gamble, the owner of the registered trademark ZzzQuil ® . Leader Nighttime Sleep Aid Berry Flavor 12FL OZ 354 mL"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions or comments? 1-866-467-2748"],"set_id":"68c79c47-11bf-4b51-ace0-723cac7a4620","spl_product_data_elements":["LEADER Nighttime Sleep-Aid DIPHENHYDRAMINE HYDROCHLORIDE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN POTASSIUM CITRATE WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness."],"storage_and_handling":["Other information each 30 mL dose contains: sodium 23 mg store at room temperature protect from light. Does not meet USP <671>"],"version":"8","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 a breathing problem such as asthma, emphysema, or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland heart disease Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep- aid. When using this product avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. 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 avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery"]}