{"active_ingredient":["Active ingredient (in each 30 mL dose cup) Diphenhydramine HCl 50 mg"],"ask_doctor":["Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty in urination due to an enlargement of the 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 • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products • with other Nighttime products"],"dosage_and_administration":["Directions • take only one dose per day (24 hours) – see Overdose warning • use dose cup adults & children 12 yrs & over 30 mL at bed time if needed or as directed by a doctor children under 12 yrs do not use Other information • each 30 mL dose cup contains: sodium 20 mg • store at 20-25°C (68-77°F) • protect from light. Does not meet USP <671>."],"dosage_and_administration_table":["<table width=\"100%\"> <col width=\"25%\"/> <col width=\"39%\"/> <tbody> <tr> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>adults &amp; children 12 yrs &amp; over</paragraph> </td> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>30 mL at bed time if needed or as directed by a doctor</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>children under 12 yrs</paragraph> </td> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>do not use</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20181210","id":"3f8ab7c6-6d47-4cd5-b9b9-092db781b3ca","inactive_ingredient":["Inactive Ingredients alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate"],"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. (1-800-222-1222)"],"openfda":{},"package_label_principal_display_panel":["Package/Label Principal Display Panel Compare to Vicks® ZzzQuil® active ingredient SleepTime Nighttime Sleep-Aid Diphenhydramine HCl 50 mg per 30 mL Not for treating Cold or Flu See Warnings Berry Flavor Non-Habit Forming ALCOHOL 10% 6 FL OZ (177 mL) Leader Sleep Time Image 1 Leader Sleep Time Image 2"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"b58e1d47-ca5f-4556-8cd1-3dc80b046567","spl_product_data_elements":["Leader SleepTime Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ALCOHOL ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 HIGH FRUCTOSE CORN SYRUP POLOXAMER 407 PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE"],"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 • each 30 mL dose cup contains: sodium 20 mg • store at 20-25°C (68-77°F) • protect from light. Does not meet USP <671>."],"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 • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products • with other Nighttime products Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty in urination due to an enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product • avoid alcoholic beverages • drowsiness will occur • do not drive a motor vehicle or operate 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."],"when_using":["When using this product • avoid alcoholic beverages • drowsiness will occur • do not drive a motor vehicle or operate machinery"]}