Label: HEVERT DETOX KIDNEY- nitric acid, apis mellifera, atropa belladonna, lytta vesicatoria, juniper berry, and solidago virgaurea flowering top liquid

  • NDC Code(s): 54532-0032-5
  • Packager: Hevert Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated July 8, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    "X" indicates a homeopathic dilution. For more information visit: www.hevertusa.com
    *
    pain relief in the urinary system
    Acidum nitricum 6X*
    Apis mellifica 3X*
    Belladonna 6X*
    Cantharis 4X*
    Juniperus communis 3X*
    Solidago virgaurea TM*
  • Uses

    For temporary relief of pain and burning sensation associated with frequent or urgent need to urinate.

    Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • Warnings

    For oral use only.

    Blood in urine, fever, nausea, vomiting, pain in kidney area or acute urinary retention may be serious.

    Consult a doctor promptly if any of these symptoms occur.

    Do not use if

    • you are allergic to bee venom

    Stop use and ask a doctor if symptoms persist for more than 5 days, worsen or new symptoms occur.

    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.

  • Directions

    • Adults and children over 12 years of age: Take 20 drops in water 3 times daily.
    • Consult a physician for use in children under 12 years of age.
  • Other information

    • Store at 68 to 77 °F.
    • Tamper Evident:
      Do not use if tamper evident strip is broken or missing from base of bottle cap.
    • To report serious adverse events, call 1-855-387-6466.
  • Inactive ingredients

    60 % ethanol V/V, purified water

  • Questions?

    1-855-387-6466

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Hevert Pharmaceuticals, LLC
    Boulder, CO 80303

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

    NDC 54532-0032-5

    HEVERT®
    DETOX
    KIDNEY

    Homeopathic Medicine

    For the kidneys and
    urinary system

    1.7 fl oz (50 ml)
    60 % alcohol V/V
    Oral drops

    Made in Germany

    hEVERT

    PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    HEVERT DETOX KIDNEY 
    nitric acid, apis mellifera, atropa belladonna, lytta vesicatoria, juniper berry, and solidago virgaurea flowering top liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54532-0032
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Nitric Acid (UNII: 411VRN1TV4) (Nitric Acid - UNII:411VRN1TV4) Nitric Acid6 [hp_X]  in 50 mL
    Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera3 [hp_X]  in 50 mL
    Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna6 [hp_X]  in 50 mL
    Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria4 [hp_X]  in 50 mL
    Juniper Berry (UNII: O84B5194RL) (Juniper Berry - UNII:O84B5194RL) Juniper Berry3 [hp_X]  in 50 mL
    Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top1 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54532-0032-51 in 1 CARTON06/15/2016
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC06/15/2016
    Labeler - Hevert Pharmaceuticals LLC (078647622)
    Registrant - Hevert Arzneimittel GmbH & Co. KG (318100617)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hevert Arzneimittel GmbH & Co. KG318100617MANUFACTURE(54532-0032)