{"active_ingredient":["Active ingredient (in each softgel) Diphenhydramine HCl 25 mg"],"ask_doctor":["Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the 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 take only one dose (2 softgels) per day (24 hours) adults & children 12 yrs & over 2 softgels at bedtime if needed or as directed by a doctor children under 12 yrs do not use"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><paragraph>adults &amp; children 12 yrs &amp; over</paragraph></td><td><paragraph>2 softgels at bedtime if needed or as directed by a doctor</paragraph></td></tr><tr><td><paragraph>children under 12 yrs</paragraph></td><td><paragraph>do not use</paragraph></td></tr></tbody></table>"],"effective_time":"20250819","id":"3c10ec86-2536-00f5-e063-6394a90a244c","inactive_ingredient":["Inactive ingredients FD&C blue no. 1, FD&C red no. 40, gelatin, glycerol, polyethylene glycol 400, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide."],"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. 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"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["BJWC (Berkley & Jensen / BJ's)"],"package_ndc":["68391-613-92"],"product_ndc":["68391-613"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049909"],"spl_id":["3c10ec86-2536-00f5-e063-6394a90a244c"],"spl_set_id":["2f476647-5727-3443-e063-6394a90afd3f"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0888670204009"]},"other_safety_information":["Other information store at 20-25° C (68-77°F) avoid excessive heat above 40°C (104°F) protect from light."],"package_label_principal_display_panel":["613T-BJ- Nighttime sleep aid 192ct carton"],"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 1-877-290-4008"],"set_id":"2f476647-5727-3443-e063-6394a90afd3f","spl_product_data_elements":["Nighttime Sleep Aid Diphenhydramine Hydrochloride POLYETHYLENE GLYCOL 400 WATER GLYCERIN SORBITAN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE GELATIN, UNSPECIFIED SORBITOL SOLUTION SHELLAC FD&C BLUE NO. 1 FD&C RED NO. 40 PROPYLENE GLYCOL TITANIUM DIOXIDE Oblong shaped 121 Purple, Translucent"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness."],"version":"2","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 difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product avoid alcoholic beverages Stop use and ask a doctor if sleeplessness persists 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 (1-800-222-1222) right away."],"when_using":["When using this product avoid alcoholic beverages"]}