{"active_ingredient":["Active ingredient (in each 30 mL) 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 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"],"dosage_and_administration":["Directions • take only one dose per day (24 hours) • only use the dose cup provided 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"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"38%\"/><col width=\"62%\"/><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 \" valign=\"top\"><paragraph>children under 12 yrs</paragraph></td><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>do not use</paragraph></td></tr></tbody></table>"],"effective_time":"20251211","id":"b2891495-9d6a-4173-bf1b-a94d7747370c","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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"openfda":{"application_number":["M010"],"brand_name":["Topcare ZZZ Sleep"],"generic_name":["DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["Topco Associates LLC"],"package_ndc":["36800-200-30","36800-200-40","36800-200-34","36800-200-50"],"product_ndc":["36800-200"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1248354","1437306"],"spl_id":["b2891495-9d6a-4173-bf1b-a94d7747370c"],"spl_set_id":["27225d04-6deb-436b-89ea-9842c487292e"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel TopCare ® health NIGHTTIME COMPARE TO VICKS ® ZZZQUIL ® ACTIVE INGREDIENT ZZZ Sleep ® DIPHENHYDRAMINE HCl 50 mg per 30 mL NIGHTTIME SLEEP-AID • Non-Habit Forming • Not for Treating Cold or Flu ALCOHOL 10% 6 FL OZ (177 mL) BERRY FLAVOR zzz sleep image"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep-aid"],"questions":["Questions or comments? 1-888-423-0139"],"set_id":"27225d04-6deb-436b-89ea-9842c487292e","spl_product_data_elements":["Topcare ZZZ Sleep 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, UNSPECIFIED FORM"],"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 contains: sodium 20 mg • store at 20-25 ° C (68-77 ° F)"],"version":"9","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 emphysema or chronic bronchitis • glaucoma • difficulty in urination due to 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 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 (1-800-222-1222)."],"when_using":["When using this product • avoid alcoholic beverages"]}