Label: ENGYSTOL- vincetoxicum hirundinaria root, sulfur tablet

  • 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 September 27, 2023

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  • INDICATIONS & USAGE SECTION

    For immune support when experiencing
    minor cold & flu symptoms: Body aches, Fatigue,
    Headache, Nausea.

  • Directions

    Adults and children 4 years and
    older: 1-2 tablets 3 times per day or as directed by a
    health practitioner. Not to exceed 6 tablets per 24
    hours. Children under 4, as directed by a health
    professional. Allow to completely dissolve in the mouth.

  • Warnings:

     If pregnant or breast-feeding, ask a
    health professional before use. Keep out of reach of
    children. If symptoms persist or worsen, a healthcare
    provider should be consulted. Do not use if known
    sensitivity to Engystol® or any of its ingredients exists.

  • Active ingredients:

     Each 300 mg tablet contains:
    *Asclepias vincetoxicum 6X, 10X, 30X 75mg each;
    *Sulphur 4X, 10X 37.5mg each. *Natural

  • Inactive ingredients:

     Lactose, Magnesium stearate

  • PURPOSE

    Immune
    Support

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    Engystol.jpg

  • INGREDIENTS AND APPEARANCE
    ENGYSTOL 
    vincetoxicum hirundinaria root, sulfur tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62795-9490
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VINCETOXICUM HIRUNDINARIA ROOT (UNII: 9R858U917W) (CYNANCHUM VINCETOXICUM ROOT - UNII:9R858U917W) VINCETOXICUM HIRUNDINARIA ROOT30 [hp_X]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62795-9490-21 in 1 CARTON01/12/2022
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/12/2022
    Labeler - Medinatura Inc (079324099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biologische Heilmittel315635359manufacture(62795-9490)
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