{"active_ingredient":["Active ingredient (in each capsule) Diphenhydramine HCl 25 mg"],"ask_doctor":["Ask a doctor before use if you have a breathing problem such as asthma, emphysema, or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland heart disease"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid"],"do_not_use":["Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products do not use with NyQuil"],"dosage_and_administration":["Directions take only one dose per day (24 hours) - see Overdose warning adults & children 12 yrs & over One dose = TWO 25 mg softgels (50 mg) at bedtime if needed or as directed by a doctor"],"dosage_and_administration_table":["<table border=\"1\"><tbody><tr styleCode=\"First Last\"><td><paragraph>adults &amp; children</paragraph><paragraph>12 yrs &amp; over</paragraph></td><td><paragraph> One dose = TWO 25 mg softgels (50 mg)</paragraph><paragraph> at bedtime if needed or as directed by a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20241121","id":"27667628-c793-e83c-e063-6394a90a1d32","inactive_ingredient":["Inactive ingredients FD&C blue #1, FD&C red #40, 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 reduces time to fall asleep if you have difficulty falling asleep"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. 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":["53345-002-02"],"product_ndc":["53345-002"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049909"],"spl_id":["27667628-c793-e83c-e063-6394a90a1d32"],"spl_set_id":["7830ce18-908a-4f86-a238-8c31cfe47ce6"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Shipping Label DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, 25 mg Quantity : 20000 Capsules NDC. No : 53345-002-02 IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. CAUTION : \"FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING\" Shipping Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"set_id":"7830ce18-908a-4f86-a238-8c31cfe47ce6","spl_product_data_elements":["DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITOL DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE oblong PC11"],"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 room temperature 15°-30°C (59°-86°F) avoid excessive heat above 40°C (104°F) and high humidity protect from light"],"version":"5","warnings":["Warnings Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products do not use with NyQuil Ask a doctor before use if you have a breathing problem such as asthma, emphysema, or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland heart disease Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid When using this product avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery 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. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery"]}