{"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":"20260126","id":"494914ff-a952-e7f9-e063-6294a90a88e1","inactive_ingredient":["Inactive ingredients FD&C Blue#1, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol, titanium dioxide, water"],"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. In case of overdose, get medical help or contact a Poison Control Center right away. 1(800)222-1222"],"openfda":{"application_number":["M010"],"brand_name":["NIGHTTIME SLEEP AID"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Prodose, Inc."],"package_ndc":["68210-4160-8"],"product_ndc":["68210-4160"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020477"],"spl_id":["494914ff-a952-e7f9-e063-6294a90a88e1"],"spl_set_id":["c4bc3efd-8ca8-22fe-e053-2a95a90aed45"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 68210-4160-8 Maximum Strength Nighttime Sleep-aid Diphenhydramine HCl 50 mg - Nighttime Sleep-Aid Helps you fall asleep Safe, Effective & Non-habit forming 8 softgels one softgel per dose Nighttime Sleep-Aid"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions or comments? 1-888-333-9792"],"set_id":"c4bc3efd-8ca8-22fe-e053-2a95a90aed45","spl_product_data_elements":["NIGHTTIME SLEEP AID DIPHENHYDRAMINE HYDROCHLORIDE FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SORBITOL TITANIUM DIOXIDE WATER DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 206;903"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness."],"version":"6","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 persist continuously for more than 2 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. 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 drinks"]}