Label: HEVERT MOTION SICKNESS RELIEF- anamirta cocculus seed, conium maculatum flowering top, and tobacco leaf tablet

  • NDC Code(s): 54532-0013-4
  • 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 August 2, 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
    Cocculus indicus 4XDizziness, nausea, vomiting
    Conium maculatum 6XDizziness
    Tabacum 4XDizziness, nausea, vomiting
  • Uses

    For prevention and temporary relief of symptoms of motion sickness, such as:

    • nausea
    • vomiting
    • dizziness

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

  • Warnings

    Stop use and ask a doctor if symptoms persist or worsen.

    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: Dissolve 2 tablets in mouth 3 times daily. In acute cases, dissolve 2 tablets in mouth 6 times daily.
    • Children 6 to 12 years of age: Dissolve 1 tablet in mouth 3 times daily. In acute cases, dissolve 1 tablet in mouth 6 times daily.
  • Other Information

    • Store at 68 to 77 °F.
    • Tamper Evident: Do not use if blister seal is broken.
    • To report serious adverse events, call 1-855-387-6466.
  • Inactive ingredients

    lactose, magnesium stearate

  • Questions?

    1-855-387-6466

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Hevert Pharmaceuticals, LLC
    Boulder, CO 80303

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Blister Pack Carton

    NDC 54532-0013-4

    HEVERT®
    MOTION
    SICKNESS
    RELIEF
    Homeopathic Medicine

    Relieves symptoms
    of motion sickness
    Quick dissolving tablets

    Made in Germany

    100 Tablets

    hEVERT

    PRINCIPAL DISPLAY PANEL - 100 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    HEVERT   MOTION SICKNESS RELIEF
    anamirta cocculus seed, conium maculatum flowering top, and tobacco leaf tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54532-0013
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED4 [hp_X]
    CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP6 [hp_X]
    TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF4 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54532-0013-410 in 1 CARTON02/01/201309/30/2020
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/01/201309/30/2020
    Labeler - Hevert Pharmaceuticals LLC (078647622)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hevert Arzneimittel GmbH & Co. KG318100617MANUFACTURE(54532-0013)