Label: HEVERT STRESS RELIEF- black cohosh, anamirta cocculus seed, cypripedium parvifolum root, strychnos ignatii seed, lilium lancifolium flowering top, passiflora incarnata flowering top, platinum, valerian, and zinc valerate dihydrate tablet

  • NDC Code(s): 54532-0010-4, 54532-0010-5
  • 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 May 26, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    „X" indicates a homeopathic dilution. For more information visit: www.hevertusa.com
    *
    relief of minor symptoms of tension and stress
    Cimicifuga racemosa 4X *
    Cocculus indicus 6X *
    Cypripedium pubescens 6X *
    Ignatia amara 6X *
    Lilium tigrinum 6X *
    Passiflora incarnata 3X *
    Platinum metallicum 8X *
    Valeriana officinalis 2X *
    Zincum valerianicum 4X *
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  • Uses

    For temporary relief of minor symptoms of tension and stress, such as:

    • restlessness
    • mild mood changes
    • temporary anxiety
    • occasional sleeplessness

    These statements have not been evaluated by the Food and Drug Administration.
    They are supported by traditional homeopathic principles.

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  • Warnings

    Do not use if

    • you are allergic to lady's slipper or orchids.

    Stop use and ask a doctor if

    • symptoms persist continuously for more than 2 weeks or worsen.

      Insomnia (sleeplessness) may be a symptom of serious underlying 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.

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  • 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.
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  • 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.
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  • Inactive ingredients

    lactose, magnesium stearate

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  • Questions?

    1-855-387-6466

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Hevert Pharmaceuticals, LLC
    Boulder, CO 80301

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  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

    NDC 54532-0010-4

    HEVERT®
    STRESS
    RELIEF
    Homeopathic Medicine

    Relieves symptoms of stress
    Non habit-forming
    Quick dissolving tablets

    Made in Germany

    100 Tablets

    hEVERT

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    HEVERT STRESS RELIEF 
    black cohosh, anamirta cocculus seed, cypripedium parvifolum root, strychnos ignatii seed, lilium lancifolium flowering top, passiflora incarnata flowering top, platinum, valerian, and zinc valerate dihydrate tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54532-0010
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH 4 [hp_X]
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED 6 [hp_X]
    CYPRIPEDIUM PARVIFOLUM ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFOLUM ROOT - UNII:21Y9GZ1LZA) CYPRIPEDIUM PARVIFOLUM ROOT 6 [hp_X]
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 6 [hp_X]
    LILIUM LANCIFOLIUM FLOWERING TOP (UNII: 6268MFA917) (LILIUM LANCIFOLIUM FLOWERING TOP - UNII:6268MFA917) LILIUM LANCIFOLIUM FLOWERING TOP 6 [hp_X]
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 3 [hp_X]
    PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY) PLATINUM 8 [hp_X]
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 2 [hp_X]
    ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B) ZINC VALERATE DIHYDRATE 4 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code H
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54532-0010-4 10 in 1 CARTON 02/15/2013
    1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:54532-0010-5 2 in 1 CARTON 02/15/2013
    2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved homeopathic 02/15/2013
    Labeler - Hevert Pharmaceuticals LLC (078647622)
    Establishment
    Name Address ID/FEI Business Operations
    Hevert Arzneimittel GmbH & Co. KG 318100617 MANUFACTURE(54532-0010)
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