Label: HEVERT DETOX INTESTINUM- eichhornia crassipes whole, okoubaka aubrevillei bark, quassia amara wood, and taraxacum officinale liquid

  • NDC Code(s): 54532-0031-5
  • 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
    Eichhornia 1Xbloating
    constipation
    Okoubaka 2Xnausea
    Quassia amara TMbloating
    Taraxacum officinale 1Xbloating
    abdominal fullness
  • Uses

    For temporary relief of symptoms of upset stomach and indigestion, such as:

    • bloating
    • abdominal fullness
    • nausea
    • constipation

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

  • Warnings

    For oral use only.

    Stop use and ask a doctor if symptoms persist for more than 7 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 54532-0031-5

    HEVERT®
    DETOX
    INTESTINUM
    Homeopathic Medicine

    Relieves symptoms
    of upset stomach
    and indigestion

    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 INTESTINUM 
    eichhornia crassipes whole, okoubaka aubrevillei bark, quassia amara wood, and taraxacum officinale liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54532-0031
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Eichhornia Crassipes Whole (UNII: 216V7S21BH) (Eichhornia Crassipes Whole - UNII:216V7S21BH) Eichhornia Crassipes Whole1 [hp_X]  in 50 mL
    OKOUBAKA AUBREVILLEI BARK (UNII: MK2074187Z) (OKOUBAKA AUBREVILLEI BARK - UNII:MK2074187Z) OKOUBAKA AUBREVILLEI BARK2 [hp_X]  in 50 mL
    QUASSIA AMARA WOOD (UNII: S5249Q85HW) (QUASSIA AMARA WOOD - UNII:S5249Q85HW) QUASSIA AMARA WOOD1 [hp_X]  in 50 mL
    TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE1 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54532-0031-51 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(54532-0031)