Label: FUCUS VESICULOSUS pellet

  • 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 November 19, 2013

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  • ACTIVE INGREDIENT HPUS

    FUCUS VESICULOSUS 1X

    (Bladderwrack)

  • PURPOSE

    IMPROVES DIGESTION, REDUCES FLATULENCE*

  • USE

    For self-limiting condition listed above or as directed by a health professional.

  • WARNINGS

    Do not use if pellet-dispenser seal is broken.

    Stop use and ask a doctor if symptoms persist more than 3 days or worsen.

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

    Keep out of reach of children.

  • DIRECTIONS

    Adults: Allow 3 or 4 pellets to dissolve in the mouth 3 times a day until symptoms are relieved or as directed by a health professional.

  • OTHER INFORMATION

    Store at room temperature.

  • INACTIVE INGREDIENTS

    Lactose, sucrose.

  • REFERENCES

    The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

    *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

  • DESCRIPTION

    80 Pellets

    Pellet dispenser

    Mfd for: HOMEOLAB USA

    3025 De L'Assomption, Montreal, QC, H1N 2H2, CANADA

    1-800-404-4666 / www.homeolab.com

    Product of Canada

  • LABEL

    IMAGE OF TUBE LABEL

  • INGREDIENTS AND APPEARANCE
    FUCUS VESICULOSUS 
    fucus vesiculosus pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-6695
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-6695-180 in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/18/2013
    Labeler - HOMEOLAB USA INC. (202032533)
    Registrant - HOMEOLAB USA INC. (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC.202032533manufacture(60512-6695)
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