Label: SEPIA PLEX- aconitum napellus, cimicifuga racemosa, lachesis mutus, melissa officinalis, platinum metallicum, sanguinaria canadensis, sepia, sulphuricum acidum, valeriana officinalis liquid

  • 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 15, 2021

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  • ACTIVE INGREDIENT

    Active ingredients
    Each drop contains:
    Aconitum napellus (Aconite) Whole Plant 6X
    Cimicifuga racemosa (Black cohosh) Root and Rhizome 3X
    Lachesis mutus (Bushmaster) Venom 8X
    Melissa officinalis (Lemon balm) Leaf and Shoot 2X
    Platinum metallicum (Platinum) 8X
    Sanguinaria canadensis (Blood root) Underground Parts 3X
    Sepia Dried Inky Secretion 3X
    Sulphuricum acidum (Sulfuric acid) 6X
    Valeriana officinalis (Valerian) Root 6X

  • PURPOSE

    Uses

    For the temporary relief of symptoms associated with menopause.

  • WARNINGS

    Warnings
    Stop use and ask a doctor if symptoms persist or worsen.
    If pregnant or breastfeeding, 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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of
    overdose, get medical help or contact a
    Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a
    health professional before use.

  • OTHER SAFETY INFORMATION

    Other information
    Do not use if seal is missing or broken.
    Store in a cool, dry place.

    Contents may not fill package in order
    to accommodate required labeling.
    Please rely on stated quantity.

  • INACTIVE INGREDIENT

    Inactive ingredients
    Ethanol (beet), glycerin, purified water

  • DOSAGE & ADMINISTRATION

    Directions
    To be taken ten minutes away from food.
    Invert bottle and shake lightly allowing
    drops to fall directly under the tongue
    or into ¼ oz of water.
    Hold contents for about 20 seconds
    and swallow.
    To promote drop flow, invert bottle and
    shake before each use.

    Dosage frequency may be increased
    up to six times daily depending on the
    severity of symptoms.
    Adults: Take 10 drops three times daily
    or as recommended by your healthcare
    practitioner.

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of symptoms associated with menopause.

    Directions
    To be taken ten minutes away from food.

    Invert bottle and shake lightly allowing
    drops to fall directly under the tongue
    or into ¼ oz of water.
    Hold contents for about 20 seconds
    and swallow.
    To promote drop flow, invert bottle and
    shake before each use.
    Dosage frequency may be increased
    up to six times daily depending on the
    severity of symptoms.
    Adults: Take 10 drops three times daily
    or as recommended by your healthcare
    practitioner.

  • PRINCIPAL DISPLAY PANEL

    62106-0117-0

    NDC 62106-0117-0

    UNDA

    plex

    SEPIA PLEX

    Homeopathic Preparation

    For the temporary relief of symptoms associated with menopause.

    Contains 31% Alcohol

    1 fl oz (30 mL)

  • INGREDIENTS AND APPEARANCE
    SEPIA PLEX 
    aconitum napellus, cimicifuga racemosa, lachesis mutus, melissa officinalis, platinum metallicum, sanguinaria canadensis, sepia, sulphuricum acidum, valeriana officinalis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-0117
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH3 [hp_X]  in 30 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM8 [hp_X]  in 30 mL
    PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY) PLATINUM8 [hp_X]  in 30 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT3 [hp_X]  in 30 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE3 [hp_X]  in 30 mL
    MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N) MELISSA OFFICINALIS2 [hp_X]  in 30 mL
    SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID6 [hp_X]  in 30 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN6 [hp_X]  in 30 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-0117-01 in 1 CARTON04/03/2017
    130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/03/2017
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN'UP401010287manufacture(62106-0117)
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