{"active_ingredient":["Diphenhydramine HCl 25 mg Diphenhydramine HCl 25 mg"],"ask_doctor_or_pharmacist":["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"],"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":["Diphenhydramine HCl 25 mg"],"dosage_forms_and_strengths":["take only one dose per day (24 hours) - see Overdose warning adults & Children 12 yrs & over One dose = TWO 25mg softgels (50mg) at bedtime if needed or as directed by a doctor"],"dosage_forms_and_strengths_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>adults &amp; Children 12 yrs &amp; over</td><td><paragraph>One dose = TWO 25mg softgels (50mg)</paragraph><paragraph>at bedtime if needed or as directed by a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20260107","id":"47d40763-f19a-a5df-e063-6394a90af7bd","inactive_ingredient":["FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink"],"indications_and_usage":["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 CAPSULE, LIQUID FILLED"],"is_original_packager":[true],"manufacturer_name":["AMZ789 LLC"],"package_ndc":["73629-007-22"],"product_ndc":["73629-007"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049909"],"spl_id":["47d40763-f19a-a5df-e063-6394a90af7bd"],"spl_set_id":["12dd2419-b2e0-5466-e063-6394a90a4221"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["Display Panel"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Nighttime sleep-aid for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep"],"set_id":"12dd2419-b2e0-5466-e063-6394a90a4221","spl_product_data_elements":["DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride capsule, liquid filled POLYETHYLENE GLYCOL, UNSPECIFIED DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C RED NO. 40 GLYCERIN WATER GELATIN SORBITOL FD&C BLUE NO. 1 PC11 Oblong"],"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 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 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 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":["avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery"]}