Label: ECHINACEA- echinacea angustifolia, hamammelis virginiana, calcarea phosphorica, hydrastis canadanesis, senega officinalis, silicea, conium, aurum muriaticum natronatum, calcarea carbonica, fucus vesiculosus, lachesis mutus tablet, orally disintegrating

  • 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 December 5, 2011

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  • Active Ingredients

    ECHINACEA ANGUSTIFOLIA 1XHPUS

    HAMAMELIS VIRGINIANA 2XHPUS

    CALCAREA PHOSPHORICA 3XHPUS

    HYDRASTIS CANADENSIS 4XHPUS

    SENEGA OFFICINALIS 4XHPUS

    SILICEA 4XHPUS

    CONIUM 4XHPUS

    AURUM MURIATICUM NATRONATUM 5XHPUS

    CALCAREA CARBONICA 5XHPUS

    FUCUS VESICULOSUS 5XHPUS

    LACHESIS MUTUS 8XHPUS

    The letters HPUS indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United Sates.

    Purpose

    FOR TEMPORARY RELIEF OF SORE THROATS AND LYMPHATIC INFLAMMATION.

    Keep out of reach of children.

    Suggested use

    Error

    Warnings

    If pregnant or breast-feeding, consult a health professional before use.

    (Read Suggested Use Section)

    Inactive Ingredients

    Faex Med. and Lactose

  • PRINCIPAL DISPLAY PANEL


    label
    MM1

  • INGREDIENTS AND APPEARANCE
    ECHINACEA 
    echinacea angustifolia, hamammelis virginiana, calcarea phosphorica, hydrastis canadanesis, senega officinalis, silicea, conium, aurum muriaticum natronatum, calcarea carbonica, fucus vesiculosus, lachesis mutus tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60986-2000
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA1 [hp_X]
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK2 [hp_X]
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) TRIBASIC CALCIUM PHOSPHATE3 [hp_X]
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL4 [hp_X]
    POLYGALA SENEGA ROOT (UNII: M7T6H7D4IF) (POLYGALA SENEGA ROOT - UNII:M7T6H7D4IF) POLYGALA SENEGA ROOT4 [hp_X]
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE4 [hp_X]
    CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP4 [hp_X]
    SODIUM TETRACHLOROAURATE (UNII: 7FT6QUT299) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM TETRACHLOROAURATE5 [hp_X]
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE5 [hp_X]
    FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS5 [hp_X]
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM8 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    Colorwhite (LIGHT BROWN) Scoreno score
    ShapeCAPSULE (ROUND TABLET) Size12mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60986-2000-2100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/1992
    Labeler - Marco Pharma International LLC. (161994277)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nestmann Pharma GmbH323426262manufacture
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