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 June 17, 2024

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  • ACTIVE INGREDIENT

    Fucus vesiculosus 200CK HPUS

    Active ingredient**: See product name on front panel (contains 0.443 mg of the active ingredient per pellet).

  • PURPOSE

  • INDICATIONS & USAGE

    Relieves headache in the forehead *

    Uses: See symptoms on front panel.

  • WARNINGS

  • STOP USE

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

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

  • INACTIVE INGREDIENT

    lactose, sucrose

  • QUESTIONS

    BoironUSA.com Info@boiron.com
    1-800-BOIRON-1     (1-800-264-7661)
    Distributed by Boiron, Inc.
    Newtown Square, PA 19073

  • SPL UNCLASSIFIED SECTION

    Do not use if pellet dispenser seal is broken.
    Contains approx.80 pellets.
    How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
    **C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FUCUS VESICULOSUS 
    fucus vesiculosus pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-2164
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS200 [kp_C]  in 200 [kp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-2164-41200 [kp_C] in 1 TUBE; Type 0: Not a Combination Product01/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2024
    Labeler - Boiron (282560473)
    Registrant - Boiron, Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-2164)
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