{"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 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"],"dosage_and_administration":["Directions take only one dose per day (24 hours) - see Overdose warning adults and children 12 yrs and over ONE dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor"],"dosage_and_administration_table":["<table border=\"1\" cellspacing=\"0\" cellpadding=\"0\"> <tbody> <tr> <td valign=\"top\"> <paragraph>adults and children 12 yrs and over</paragraph> </td> <td valign=\"top\"> <paragraph> ONE dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20191220","id":"dc48a41e-2ea8-4e30-b1a9-b7b64f8082bf","inactive_ingredient":["Inactive ingredients FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, and white edible ink"],"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."],"openfda":{},"overdosage":["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."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL PuraVation Nighttime SLEEP AID Diphenhydramine HCl - 25 mg EACH 12 LIQUID-FILLED SOFTGELS NDC 51013-181-02 Carton Label"],"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 toll free: 1-855-215-8180"],"set_id":"310f58b6-a425-4513-9c0e-5c5439ede527","spl_product_data_elements":["Nighttime SLEEP AID Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITOL clear 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":"2","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 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"]}