{"active_ingredient":["Diphenhydramine HCl Active Ingredient (in each softgel) Purpose Diphenhydramine HCl 25 mg Nighttime Sleep-Aid"],"active_ingredient_table":["
Active Ingredient (in each softgel)
Purpose
Diphenhydramine HCl 25 mg
Nighttime Sleep-Aid
"],"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 2 softgels per day (24 hours) adults & children 12 years and over take 2 softgels at bedtime if needed, or as directed by a doctor children under 12 years do not use"],"dosage_and_administration_table":["
adults & children 12 years and over
take 2 softgels at bedtime if needed, or as directed by a doctor
children under 12 years
do not use
"],"effective_time":"20250917","id":"3f053ed8-8c2a-be03-e063-6294a90ae5b7","inactive_ingredient":["Inactive ingredients FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide."],"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 Keep out of reach of children."],"openfda":{"application_number":["M010"],"brand_name":["AXIV - VroZzz"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Vivunt Pharma LLC"],"package_ndc":["82706-014-01"],"product_ndc":["82706-014"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049909"],"spl_id":["3f053ed8-8c2a-be03-e063-6294a90ae5b7"],"spl_set_id":["131a60cf-02ec-5a5b-e063-6294a90abd1f"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0850047780614"]},"overdosage":["Overdose warning Do not take more than recommended dosage. In case of overdose, get medical help or contact a Poison Control Center. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Compare to VICKS® ZzzQuil® Nighttime Sleep-Aid LiquidCaps™ active ingredient* NDC 82706-014-01 AXIV - VroZzz Sleep Aid For Nighttime Use Fast Acting Non-Habit Forming Diphenhydramine HCl 72 Softgels** **Liquid-filled capsules 72"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active Ingredient (in each softgel) Purpose Diphenhydramine HCl 25 mg Nighttime Sleep-Aid"],"purpose_table":["
Active Ingredient (in each softgel)
Purpose
Diphenhydramine HCl 25 mg
Nighttime Sleep-Aid
"],"set_id":"131a60cf-02ec-5a5b-e063-6294a90abd1f","spl_product_data_elements":["AXIV - VroZzz Diphenhydramine Hydrochloride FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN GLYCERIN METHYLPARABEN POLYETHYLENE GLYCOL 400 PROPYLPARABEN WATER SORBITOL TITANIUM DIOXIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE AXIV"],"spl_unclassified_section":["Drug Facts","This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark VICKS® ZzzQuil® Nighttime Sleep-Aid LiquidCaps™. Lic. No.: \"DD/DRUGS/DD/416\" Distributed by: Vivunt Pharma LLC 8590 w 74TH Court, Suite 1901 Miami, FL 33156-3178 Made in India www.vivunt.live"],"stop_use":["Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of a serious underlying medical illness."],"storage_and_handling":["Other information store between 20-25°C (68-77 °F) tamper-evident: Do not use if carton is open or if the foil inner seal is broken or missing."],"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 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, consult your doctor. Insomnia may be a symptom of a serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children Keep out of reach of children. Overdose warning Do not take more than recommended dosage. In case of overdose, get medical help or contact a Poison Control Center. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"when_using":["When using this product avoid alcoholic beverages"]}