{"active_ingredient":["Active ingredient (in each softgel) Diphenhydramine Hydrochloride USP 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"],"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":"20260127","id":"47c5b5fc-5f4a-cd15-e063-6294a90a45aa","inactive_ingredient":["Inactive ingredients Propylene Glycol, Polyethylene Glycol 600, Polyethylene Glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD & C Blue No.1, Purified Water"],"indications_and_usage":["Uses 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 right away."],"openfda":{"application_number":["M010"],"brand_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["SOFTGEL HEALTHCARE PRIVATE LIMITED"],"package_ndc":["35916-0438-1","35916-0438-3"],"product_ndc":["35916-0438"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020477"],"spl_id":["47c5b5fc-5f4a-cd15-e063-6294a90a45aa"],"spl_set_id":["0e45d0e8-3741-7cee-e063-6394a90a2de5"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0335916043811"]},"package_label_principal_display_panel":["Principal Display Panel Compare to the active ingredient Unisom ® SleepGels ® SleepGels NDC 35916-0438-1 Diphenhydramine Hydrochloride Capsules USP 50 mg NIGHTTIME SLEEP-AID ♦ fall asleep fast ♦ sleep soundly ♦ safe, non-habit forming 100 SoftGels** **liquid-filled capsules one softgel per dose bottle","Bulk Package Label label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"set_id":"0e45d0e8-3741-7cee-e063-6394a90a2de5","spl_product_data_elements":["DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE POLYETHYLENE GLYCOL 600 WATER PROPYLENE GLYCOL POLYETHYLENE GLYCOL 400 SORBITOL FD&C BLUE NO. 1 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE GELATIN GLYCERIN (Transparent) (Oval)"],"stop_use":["Stop use and ask a doctor if sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness."],"version":"4","warnings":["Warnings Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin"],"when_using":["When using this product avoid alcoholic drinks"]}