{"active_ingredient":["Active ingredient (in each softgel) Diphenhydramine HCl 50 mg"],"ask_doctor":["Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers."],"do_not_use":["Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin"],"dosage_and_administration":["Directions adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor"],"effective_time":"20250603","id":"85656d4e-1308-4a7b-b0be-f9c19a5f4a37","inactive_ingredient":["Inactive ingredients FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitol sorbitan, white ink"],"indications_and_usage":["Use for relief of occasional sleeplessness."],"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 (1-800-222-1222) right away."],"openfda":{"application_number":["M010"],"brand_name":["Nighttime Sleep Aid maximum strength"],"generic_name":["DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["Cardinal Health (Leader) 70000"],"package_ndc":["70000-0527-1"],"product_ndc":["70000-0527"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020477"],"spl_id":["85656d4e-1308-4a7b-b0be-f9c19a5f4a37"],"spl_set_id":["546e4fda-6eb2-4358-840e-e2473bf7f352"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0096295138801"]},"package_label_principal_display_panel":["Principal Display Panel COMPARE TO UNISOM® SLEEPGELS® active ingredient† Sleep Aid Diphenhydramine HCl, 50 mg | Nighttime Sleep-Aid Fall Asleep Fast Sleep Soundly Wake Up Refreshed SOFTGELS One Softgel Per Dose †This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Unisom® SleepGels®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313","Package Label Diphenhydramine HCl, 50 mg, Nighttime Sleep-Aid Leader Sleep-Aid Diphenhydramine HCl, 50 mg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST"],"set_id":"546e4fda-6eb2-4358-840e-e2473bf7f352","spl_product_data_elements":["Nighttime Sleep Aid maximum strength Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 GELATIN GLYCERIN LECITHIN, SOYBEAN POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITAN SORBITOL LIGHT MINERAL OIL MANNITOL PC5 Capsule (oval)"],"stop_use":["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."],"storage_and_handling":["Other information store between 15-30°C (59-86°F)"],"version":"9","warnings":["Warnings Do not use for children under 12 years of age 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 trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product avoid alcoholic drinks. 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"when_using":["When using this product avoid alcoholic drinks."]}