Label: AMBRA GRISEA- ambergris 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 March 28, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Ambra grisea

    6C,12C,15C,30C,200CK

  • PURPOSE

  • INDICATIONS & USAGE

    Ocassional sleeplessness with hypersensitivity*

  • 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

    5 pellets 3 times a day until symptoms are relieved

  • SPL UNCLASSIFIED SECTION

    Do not use if pellet dispenser seal is broken

    contains approx 80 pellets

  • INACTIVE INGREDIENT

    lactose, sucrose

  • QUESTIONS

    1-800-BOIRON-1

    Newtown Square, PA 19073-3267

    info@boironusa.com

  • SPL UNCLASSIFIED SECTION

    These "Uses" have not been evaluated by the FDA

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    AMBRA GRISEA 
    ambergris pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-0221
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMBERGRIS (UNII: XTC0D02P6C) (AMBERGRIS - UNII:XTC0D02P6C) AMBERGRIS6 [hp_C]  in 6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-0221-416 [hp_C] in 1 TUBE; Type 0: Not a Combination Product03/03/1983
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/03/1983
    Labeler - Boiron (282560473)
    Registrant - Boiron, Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-0221)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron380022322manufacture(0220-0221)