{"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 asthma, 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: take 1 softgel (50 mg) at bedtime if needed, or as directed by adoctor"],"effective_time":"20241125","id":"27c77e04-8cf5-f49c-e063-6394a90a7ba6","inactive_ingredient":["Inactive ingredients FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. Wuhan, Hubei 430206, China"],"indications_and_usage":["Uses for the 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":["Humanwell PuraCap Pharmaceutical (Wuhan), Ltd."],"package_ndc":["53345-022-01"],"product_ndc":["53345-022"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020477"],"spl_id":["27c77e04-8cf5-f49c-e063-6394a90a7ba6"],"spl_set_id":["50d74111-6d1b-4681-a264-f7e550320259"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Shipping Label DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, 50 mg Quantity : 12000 Capsules NDC. No : 53345-022-01 IMPORTANT: Inspect immediately upon receipt. This is a bulk shipment, intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. Store at 15-30°C (59-86°F) CAUTION : \"FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING\" Shipping Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"set_id":"50d74111-6d1b-4681-a264-f7e550320259","spl_product_data_elements":["DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITOL DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE oblong 656"],"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."],"storage_and_handling":["Other information store at 15°-30°C (59°-86°F)"],"version":"3","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 asthma, 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 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."],"when_using":["When using this product avoid alcoholic drinks"]}